InQwire Amplatz Guide Wire
Device Facts
| Record ID | K254137 |
|---|---|
| Device Name | InQwire Amplatz Guide Wire |
| Applicant | Merit Medical Ireland, Ltd. |
| Product Code | DQX · Cardiovascular |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
Indications for Use
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
Device Story
InQwire Amplatz Super Stiff Guidewire; stainless-steel flat wire coil with internal stainless-steel ground core wire; PTFE coated. Available in 0.035" and 0.038" diameters; lengths 75-260cm; straight or 3mm J-tip configurations. Used by clinicians in diagnostic/interventional procedures to facilitate device placement. Core wire welded to coil at ends; spot weld 22cm from distal end; open pitch distal coil section for flexibility. Supplied in spiral dispenser with flush port and introducer. Device provides mechanical support/track for catheter navigation; benefits patient by enabling precise device delivery during vascular procedures.
Clinical Evidence
No clinical data. Bench testing only. Testing included dimensional verification, simulated use, coating integrity, particulate evaluation, lubricity, flex testing, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, blood loop, complement activation, PTT, and platelet/leukocyte counts). All results met acceptance criteria.
Technological Characteristics
Materials: Stainless steel core/coil, PTFE coating. Dimensions: 0.035"/0.038" diameter; 75-260cm length. Sensing/Actuation: Mechanical guide wire. Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 11070, ISO 10993-1, ISO 10993-7, ASTM F1980, ASTM D4169.
Indications for Use
Indicated for facilitating the placement of devices during diagnostic and interventional procedures in patients requiring such interventions.
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
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 22, 2026
Merit Medical Ireland, Ltd.
Brian Coughlan
Principal Regulatory Affairs Specialist
Parkmore Business Park W.
Galway,
Ireland
Re: K254137
Trade/Device Name: InQwire Amplatz Super Stiff Guidewire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: DQX
Dated: April 22, 2026
Received: April 22, 2026
Dear Brian Coughlan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254137 - Brian Coughlan
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K254137 - Brian Coughlan
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Sincerely,
JENNY R. KATSNELSON
Digitally signed by JENNY R. KATSNELSON -S
Date: 2026.05.22 10:27:23 -04'00"
for Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K254137 | |
| Device Name InQwire Amplatz Super Stiff Guidewire | |
| Indications for Use (Describe) Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional 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." | |
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K254137
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510(k) Summary
| | Submitter Name: | Merit Medical Systems, Inc. |
| --- | --- | --- |
| | Address: | 1600 West Merit Parkway South Jordan, UT 84095 |
| | Telephone Number: | (+353) 91 703700 |
| | Fax Number: | (+353) 91 680104 |
| | Contact Person: | Brian Coughlan |
| | Registration Number: | 1721504 |
| General Provisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| | Address: | Parkmore Business Park Parkmore, Galway, Ireland |
| | Telephone Number: | (+353) 91 703700 |
| | Fax Number: | (+353) 91 680104 |
| | Contact Person: | Brian Coughlan |
| | Date of Preparation: | 19th December 2025 |
| | Registration Number: | 9616662 |
Trade Name: InQwire® Amplatz Super Stiff Guidewire
Common/Usual Name: Guide Wire
Class: II
Product code: DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Regulation Medical Specialty Cardiovascular
Subject Device
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| 510(k) Summary | |
| --- | --- |
| Predicate Device | Trade Name: InQwire® Amplatz Super Stiff Guidewire |
| | Class: II |
| | Product code: DQX |
| | Classification Name: Wire, Guide, Catheter |
| | Regulation Number: 21 CFR 870.1330 |
| | Regulation Medical Specialty Cardio vascular |
| | Premarket Notification: K163575 & K170700 |
| | Manufacturer: Merit Medical Systems Inc. |
| Device Description | Merit's InQwire Amplatz Super Stiff Guide Wires are 0.035" and 0.038" diameter with lengths of 75cm, 145cm, 180cm, 220cm or 260cm. The distal tip of the guide wire can be either Straight or with a 3mm J. The guide wire consists of a stainless-steel flat wire coil with a stainless-steel ground core wire placed inside. The assembled guide wire is spray coated with PTFE. The core wire has different ground distal profiles providing different stiffness's to meet clinical needs. For all the wire parts, the core wire is welded to the coil at the distal and proximal end. There is also a spot weld approx. 22cm from the distal end of the guide wire. The distal end of the coil has an open pitch section over approx. 7cm to give the end of the wire greater flexibility. The wires are placed in spiral dispenser with flush port and introducer. The dispenser with wire is then placed in a poly/Tyvek pouch and packaged 5 pouches per carton with one IFU |
| Indications for Use | Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures. |
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| 510(k) Summary | |
| --- | --- |
| Comparison to Predicate | Technological characteristics of the subject Merit InQwire Amplatz Super Stiff Guide Wire are substantially equivalent to those of the predicate Merit InQwire Amplatz Super Stiff Guide Wire (K163575, K170700). An alternate PTFE coating known as “Discrete coating” has been qualified at Merit Medical Coatings B.V. (Venlo, Netherlands). In addition to employing an alternate coating facility, there are formulation differences between the coating solutions used in the predicate and subject devices. The alternate coating process and formulation will apply to the full range of InQwire Amplatz Super Stiff Guidewires. The stainless steel core wire and coil wire of the subject Merit InQwire Amplatz Super Stiff Guidewire remain unchanged from the predicate InQwire Amplatz Super Stiff Guidewire (K163575, K170700). Based on the information presented herein, the subject Merit InQwire Amplatz Super Stiff Guide Wire is substantially equivalent to the predicate Merit InQwire Amplatz Super Stiff Guide Wire [K163575, K170700]. |
| Safety & Performance Tests | No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Safety and Performance tests were performed on the subject Merit InQwire Amplatz Super Stiff Guide Wire in accordance with protocols based on requirements outlined in guidance’s and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence with the predicate device. Where appropriate, the tests were based on the requirements of the following documents: • FDA Guidance - “Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recommended Labelling” – October 2019 • FDA Guidance – “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” – January 2016 |
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# 510(k) Summary
- ISO 11070:2014/Amd 1:2018, Sterile Single-Use Intravascular Catheter Introducers.
- ISO 11135:2014/Amd 1: 2018 Sterilization of health care products-Ethylene oxide:- Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems.
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process.
- FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff – September 2020.
- ISO 10993-7:2008/AMD1:2019, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. The following is a list of all testing that was successfully completed:
# Performance Non-Clinical Testing-Bench
- Dimensional Verification/Size Designation
- Finished Wire Surface (Visual Inspection)
- Simulated Use
- Coating Integrity
- Particulate Evaluation
- Lubricity
- Flex Testing
- Cytotoxicity
- Guinea Pig Maximization Sensitization Test
- Intracutaneous Irritation Test
- Acute Systemic Toxicity
- USP Rabbit Pyrogen Study
- Hemolysis – Direct Contact and Extract Method
- In-vitro Blood Loop Assay
- Complement Activation Assay
- Partial Thromboplastin Time (PTT) Assay
- Heparanized Platelet and Leukocyte Count Assay
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| 510(k) Summary | |
| --- | --- |
| | All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire, met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices. |
| Summary of Substantial Equivalence | Based on the comparisons noted the subject Merit InQwire Amplatz Super Stiff Guide Wire meets the requirements that are considered essential for its intended use and is substantively equivalent to the Predicate Merit InQwire Amplatz Super Stiff Guide Wire (K163575, K170700). |
