Who is the manufacturer of SavvyWire?

Opsens, Inc. filed the 510(k) submission for SavvyWire (K213854).

What is the FDA product code for SavvyWire?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SavvyWire?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SavvyWire?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SavvyWire

Q: What are the predicate devices for SavvyWire?

OptoWire III (K191907); Wattson Temporary Pacing Guidewire (K192454); Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) (K151244); OptoMonitor 3 (K202943).

K213854 · Opsens, Inc. · DQX · Sep 14, 2022 · Cardiovascular

Device Facts

Record ID	K213854
Device Name	SavvyWire
Applicant	Opsens, Inc.
Product Code	DQX · Cardiovascular
Decision Date	Sep 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

Device Story

SavvyWire™ is a 0.035" structural guidewire integrating pressure sensing and temporary pacing capabilities; used during TAVR procedures. Input: fiberoptic pressure signals from heart chambers; electrical pacing signals from external pulse generator. Transformation: fiberoptic sensor transmits pressure data to OptoMonitor 3; unipolar electrode transmits pacing pulses to heart. Output: hemodynamic parameters (valve gradients, pressure) displayed on OptoMonitor 3; pacing stimulus to myocardium. Used in cath lab/OR by interventional cardiologists. Benefits: enables simultaneous valve positioning, hemodynamic monitoring, and rapid ventricular pacing with a single device, reducing procedural complexity and vascular access requirements.

Clinical Evidence

Prospective, single-arm, two-center study (n=20) in patients ≥18 years undergoing TAVR for severe symptomatic aortic stenosis. Primary endpoints: device functionality for rapid pacing, valve delivery, and pressure measurement. Results confirmed successful rapid ventricular pacing and THV system positioning with both balloon-expandable and self-expandable valves. No new safety concerns identified.

Technological Characteristics

0.035" stainless steel guidewire; fiberoptic pressure sensor; unipolar pacing electrode. PTFE shaft coating. System includes OptoMonitor 3 (LCD, touchscreen, fiberoptic input). Sterilized via EtO. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients ≥18 years undergoing TAVR procedures due to severe symptomatic aortic stenosis. Used to introduce/position interventional devices, measure intracardiac pressure, and provide temporary intracardiac pacing. Contraindicated for use in cerebral vasculature and in patients with absence of anti-coagulation therapy.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

OptoWire III (K191907)
Wattson Temporary Pacing Guidewire (K192454)
Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) (K151244)
OptoMonitor 3 (K202943)

Reference Devices

Pacel™ Bipolar Pacing Catheters (K152784)

Related Devices

K241418 — OptoMonitor 3 · Opsens, Inc. · Feb 12, 2025
K240864 — PacePro Wire · Opsens, Inc. · May 24, 2024
K192454 — Wattson Temporary Pacing Guidewire · Vascular Solutions · Jan 15, 2020
K210235 — Verrata PLUS Pressure Guide Wire · Volcano Corporation · Apr 15, 2021
K251367 — OptoMonitor 3 · Opsens, Inc. · Jan 16, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 14, 2022 Opsens Inc. % Christina Henza Consultant Ultra Lifescience Solutions, Inc. 2811 Milton Ave, #409 Janesville, Wisconsin 53545 Re: K213854 Trade/Device Name: SavvyWire™ and OptoMonitor 3 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO, LDF Dated: August 9, 2022 Received: August 9, 2022 Dear Christina Henza: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K213854 Device Name SavvyWire™ Indications for Use (Describe) The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K213854 Device Name OptoMonitor 3 Indications for Use (Describe) The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary SavvyWire™ #### SUBMITTER । . Address: Opsens, Inc. 750, Boulevard du Parc Technologique Quebec (Quebec) G1P 4S3 Phone: 418.781.0333 ext 3408 Fax Number: 418-781-0024 Contact Person: Marc Chaunet, Regulatory Affairs and Quality System Director Email: marc.chaunet@opsens.com Date Prepared: September 13, 2022 #### 2. DEVICE Name of Device: SavvyWire™ and OptoMonitor 3 Common or Usual Name: structural wire with pacing and pressure sensing Classification name: Wire, guide, catheter; Transducer, pressure, catheter tip, electrode, pacemaker, temporary Regulatory Class: II Product Code: DQX, DXO, LDF #### PREDICATE DEVICE ന് The proposed SavvyWire™ is substantially equivalent to the Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 (Primary Predicate), and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Secondary predicate], with the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on 06/11/2015 used as a primary reference device. The primary and secondary predicates (Predicate #2) are included to support the pressure sensing and pacing indications / technologies as indicated below in accordance with the multiple predicates example 4 for a multi-parameter device from FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on: July 28, 2014. The Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on 06/11/2015 is used as a reference #1) for the mechanical testing performed on the SavvyWire to demonstrate substantial equivalence. The Pacel™ Bipolar Pacing {5}------------------------------------------------ Catheters cleared in K152784 on 10/22/2015 is used as a secondary reference #2) device to support the pacing function. Bundled together with this new device is a minor change to the OptoMonitor 3 software included in K202943 cleared on 11/24/2020 (Predicate #3) which expands the software to include a separate TAVI interface for use with the new wire. The predicate and reference devices have not been subject to a design-related recall. #### DEVICE DESCRIPTION 4. The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update. #### ട. INDICATIONS FOR USE SawyWire™: The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. OptoMonitor 3: The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during transcatheter aortic valve procedures. #### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The proposed SavvyWire™ is substantially equivalent to the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244 on on 06/11/2015 [primary predicate], Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 [Secondary Predicate], and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Tertiary predicate]. The Pacel™ Bipolar Pacing Catheters cleared in K152784 on 10/22/2015 is used as a reference device to support the pacing function. The secondary and tertiary predicates are included to support the pressure sensing and pacing indications / technologies as indicated below in accordance with the multiple predicates example 4 for a multi-parameter device from FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on: July 28, 2014. Bundled together with this new device is a minor change to the OptoMonitor 3 software included in K202943 cleared on 11/24/2020 (Predicate 4) which expands the software to include a separate TAVI {6}------------------------------------------------ interface for use with the SavvyWire™. It is appropriate to bundle the two devices because they are intended to be used together as a system during a therapeutic or diagnostic procedure. The proposed SavvyWire™ indications for use are a blend of the three predicate devices since the proposed device includes functionalities supported by each of these. The OptoMonitor 3 indications were updated slightly to encompass the new modality including addition of pressure measurements in heart chambers and addition of measurements such as aortic valve gradients during transcatheter aortic valve replacement procedures. The technological characteristics of the proposed SawyWire™ encompass the functionalities of the predicate and reference devices including functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart). Each of these functions is fully supported by the relevant predicate/reference devices. Beyond the major difference of combining these functionalities, there is a slight difference in the pacing wire. The SavvyWire™ is unipolar where the reference device and predicate device 3 are bipolar. This necessitates the use of a separate patient electrode for the positive connection to the external pulse generator. The pacing of the SavvyWire™ is tested to be equivalent to that of the reference device, Pacel™ Bipolar Pacing Catheters in an animal study comparing the two devices and clinical performance is also confirmed via a clinical study. No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities. Therefore, the proposed devices, SavvyWire™ and OptoMonitor 3 with TAVI meet substantial equivalence requirements with regards to the legally marketed predicate 1) the Lake Region Medical Pre-Formed Guidewire (Boston Scientific Safari² Pre-Shaped TAVI Guidewire) cleared in K151244, (Predicate 2) OptoWire III cleared in K191907, (Predicate 3) Watson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020, (Predicate OptoMonitor 3 cleared in K202943 and the reference device, Pacel™ Bipolar Pacing Catheters cleared in K152784. For detailed comparison, refer to the Substantial Equivalence tables on the following pages. Note that the comparison of the SavvyWire™ is included in Table 1: SavvyWire™ while the comparison for the OptoMonitor 3 is included in Table 2:OptoMonitor 3 with TAVI. | SavvyWire ™ | | | | | | | |-------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed Device | Predicate 1 (Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | | | Regulatory Information | Name | SavvyWire™ | Pre-Formed Guidewire (BSC Safari2) | OptoWire III | Pacel Bipolar Pacing Catheters | Wattson Temporary Pacing Guidewire | | | 510(k)# | K213854 | K151244 | K191907 | K152784 | K192454 | | | Predicates | K151244, K191907 | K130798 | K152991 | K875059 | K181001, K800298 | | | Product Code | DQX, DXO, LDF | DQX | DQX, DXO | LDF | DQX, LDF | | | Class | 2 | 2 | 2 | 2 | 2 | | SavvyWire™ | | | | | | | | | Proposed Device | Predicate 1 (Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | | | | Regulation Number | 870.1330, 870.2870, 870.3680 | 870.2870 | 870.1330, 870.2870 | 870.3680 | 870.1330, 870.3680 | | | Regulation Generic Name | Wire, guide, catheter; Transducer, pressure, catheter tip, electrode, pacemaker, temporary | Wire, guide, catheter; | Wire, guide, catheter; Transducer, pressure, catheter tip | Electrode, pacemaker, temporary | Wire, guide, catheter; Electrode, pacemaker, temporary | | | Regulation Intended Use | Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse | Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. | Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing. | The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. | Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. | | SavvyWire ™ | | | | | | | | | Proposed Device | Predicate 1 (Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | | | | Indications | The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavvyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. | The Pre- Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures. | To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease. | The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording | The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart , including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure. | | SavvyWire™ | | | | | | | | | | Proposed Device | Predicate 1 (Primary Predicate) | Predicate 2 | Reference Device | Predicate 3 | | | Contraindications | Cerebral vasculature & absence of anti- coagulation therapy | Cerebral vasculature | Cerebral vasculature | Patients with recurrent sepsis or with a hypercoagulable state should not be considered candidates for transvenous catheters since the catheter could serve as a focal point for septic or bland thrombus formation. In addition, patients with a mechanical tricuspid valve should not be considered for ventricular pacing. | The guidewire is contraindicated for use in the coronary arteries and in the cerebrovascular. | | | Prescription Use | Rx Only | Rx Only | Rx Only | Rx Only | Rx Only | | | System Components | Sterile, disposable guidewire | Sterile, disposable guidewire | Sterile, disposable guidewire | Sterile, disposable catheter | Sterile, disposable catheter | | | Pressure Sensing & Signal Transmission Technology | Fiberoptic sensor & fiber bundle embedded in guidewire. | None. | Fiberoptic sensor & fiber bundle embedded in guidewire. | None | None | | | Sterile, Single Use Patient Contact Component? | Yes | Yes | Yes | Yes | Yes | | | Guidewire OD | 0.035" | 0.035" | 0.014" | Multiple catheter sizes available. | 0.035" | | | Guidewire Length | 280 cm | 275 cm | 180 cm | 110 cm | 280 cm | | | Guidewire Shaft Material | Stainless steel | Stainless steel | Stainless Steel, Nitinol | Stainless steel | Stainless Steel | | Technological Characteristics | Tip Coating | None (Stainless steel) | Teflon spray coating (PTFE) | None (Platinum- Tungsten alloy) | None (Stainless steel) | None (Stainless steel) | | | Shaft Coating | Teflon (PTFE) | Teflon (PTFE) | Teflon (PTFE) | Proprietary blend | Fluropolymer outer | | | Intermediate Section Coating | Teflon (PTFE) | Teflon (PTFE) | PET + Hydrophilic coating…

SavvyWire

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