SimplGuide
Device Facts
| Record ID | K261242 |
|---|---|
| Device Name | SimplGuide |
| Applicant | Pendracare |
| Product Code | DYB · Cardiovascular |
| Decision Date | Jun 25, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Indications for Use
The SimplGuide guiding sheath is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The SimplGuide guiding sheath is intended to be used in the coronary or peripheral vascular system.
Device Story
SimplGuide is a guiding sheath (GS) and vessel dilator (VD) system used by clinicians to provide a pathway for therapeutic/diagnostic devices into coronary or peripheral vasculature. The device is advanced over a 0.035" guidewire. It features a reinforced body, distal radiopaque marker, and hydrophilic coating on the distal 75cm. The device is operated manually. It facilitates interventional procedures by maintaining access and guiding instruments to target sites. It is a single-use, sterile device.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-4, -5, -7, -10, -11, -18, -23) and performance testing (inner/outer diameter, kink resistance, radial stiffness, coating integrity, pull force, radiopacity, and USP <788> particulate testing).
Technological Characteristics
Reinforced sheath with vessel dilator. Materials: Inner layer (PolyAmide/PolyEthylene blend), outer layer (Nylon/polyether-blok-amide), stainless steel reinforcement, radiopaque marker (Nylon with Tungsten). Hydrophilic coating (Polyvinylpyrrolidone). Sterilization: Ethylene Oxide (ISO 11135-1, SAL 10^-6). Dimensions: 100cm length, 2.10mm ID, 2.48mm OD. Straight tip configuration. No software or electronics.
Indications for Use
Indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site.
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Predicate Devices
- R2P Destination Slender Guiding Sheath (K193125)
Reference Devices
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 25, 2026
Pendracare
Erendira Rodriguez
Director of Quality Assurance and Regulatory Affairs
Van Der Waalspark 20-22
Leek, 9351VC
Netherlands
Re: K261242
Trade/Device Name: SimplGuide
Regulation Number: 21 CFR 870.1340
Regulation Name: Catheter Introducer
Regulatory Class: Class II
Product Code: DYB
Dated: April 15, 2026
Received: April 15, 2026
Dear Erendira Rodriguez:
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'
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K261242 - Erendira Rodriguez
Page 2
(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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K261242 - Erendira Rodriguez
Page 3
Sincerely, **FINN E. DONALDSON - S** Digitally signed by FINN E. DONALDSON -S
Date: 2026.06.25
07:59:09 -04'00'
Finn Donaldson
Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261242
Device Name
SimplGuide
Indications for Use (Describe)
The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site.
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.
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 1 of 7
# **510(k) Summary**
Per 21 CFR 807.92
**A. Submitter information (807.92 (a) (1))**
**Prepared by:**
Eréndira Rodríguez
Quality Assurance and Regulatory Affairs Director
PendraCare International B.V.
Tel +31 85 0073 000
**Owner/Operator:**
***Manufacturer (510(k) Applicant)***
PendraCare International B.V.
Van der Waalspark 22
9351VC, Leek
The Netherlands
Registration: 3005635992
FEI: 3005635992
***Sterilization Facility***
Sterigenics Belgium Petit Rechain S.A.
Zoning Industriel De Petit-Rechain
Avenue Andre Ernst 21
Verviers Liege, BE B-4800
Registration Number: 3005941719
FEI Number: 3002807111
**Contact Person:**
Eréndira Rodríguez
Quality Assurance and Regulatory Affairs Director
PendraCare International B.V.
Van der Waalspark 22
9351VC, Leek
The Netherlands
Tel +31 85 0073 000
Email: erendira.rodriguez@welling.com
**Date Prepared:**
April 14, 2026
**B. Device Name**
| Trade or proprietary name: | SimplGuide |
| --- | --- |
| Common or usual name: | Guiding Sheath |
| Classification name: | Class II, 21 CFR 870.1340 |
| Review Panel: | Cardiovascular |
| Product Code: | DYB |
**C. Predicate Device information**
The legally marketed devices which the 510(k) used for claiming equivalence are
- R2P Destination Slender Guiding Sheath (K193125) (Predicate device)
- Convey 7F Guiding Catheters (K132197, July 11, 2013) (Reference device)
- Primum Hydrophilic Guiding Catheter ( K250972, June 29, 2025) (Reference device)
{5}
Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 2 of 7
# D. Device Description
Component 1: The SimplGuide guiding sheath (GS) consists of a reinforced body with a hub and strain relief at the proximal end and a radiopaque marker band and distal tip at the distal end. The distal part of the GS is straight without a shape. A part of the GS body features a hydrophilic coating. The GS is developed without side holes.
Component 2: The vessel dilator (VD) is supplied together with the GS. The combination GS and VD is introduced through the skin tissue into the vascular system of the patient, and advanced through the vasculature to the target location over a routinely used 0.035" guidewire.
The Design Inputs and Design Outputs are gathered in attachment 1 (Design Input – Design Output Table) per SOP R&D-006 (Design Input – Design Output).
# E. Intended use of Device
The SimplGuide guiding sheath is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The SimplGuide guiding sheath is intended to be used in the coronary or peripheral vascular system.
# F. Indications for Use
The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site.
# G. Technological Characteristics / Substantial Equivalence
See Comparison tables (Table 1 and Table 2) below.
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Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 3 of 7
**Table 1: Comparison Predicate Device and Proposed Device**
| | Predicate Device | New Proposed Device |
| --- | --- | --- |
| | **R2P Destination Slender guiding sheath (6F) (K193125)** | **SimplGuide guiding sheath (6F) (K261242)** |
| **Product Code** | **DYB (Introducer, catheter)** | **Same** |
| **Trade Name** | R2P™ Destination Slender™ Guiding Sheath | SimplGuide |
| **Indications for use** | R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery. | The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site. |
| **Operating Principle** | Operated manually or by a manual process | Same |
| **Design** | Length: 75cm, 85cm, **95cm, 105cm**, 119cm and 149cm | Length: 100 cm |
| | ID: 2.2mm | ID: 2.10mm |
| | OD: 2.5mm | OD: 2.48mm |
| *- design / construction* | Sheath, Dilator, Hemostatic Valve with side tube and three-way stopcock | Sheath, Vessel Dilator |
| *- outer hydrophilic coating* | Yes | Yes |
| *- hydrophilic coating length* | Hydrophilic Coating: full usable length | Hydrophilic Coating: 75cm distal length |
| *- tip configuration* | Straight tip | Same |
| *- tip visibility material* | Radiopaque Tip: Nylon with Tungsten | Same |
| *- body reinforcement config* | Coiled reinforcement | Braided reinforcement |
| *- hub* | Nylon | Nylon Colorant |
| **Vessel dilator** | Vessel dilator included | Same |
| **Vessel dilator extended length** | 5cm | Same |
| **Hemostasis device** | Hemostasis device: cross cut hemostatic valve, three way stopcock | No hemostasis device included |
| **Materials** | Inner layer: PTFE | Inner layer: PolyAmide/PolyEthylene blend |
| | Outer Layer: Nylon / polyether-blok-amide | Same |
{7}
Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 4 of 7
| | Predicate Device | New Proposed Device |
| --- | --- | --- |
| | **R2P Destination Slender guiding sheath (6F) (K193125)** | **SimplGuide guiding sheath (6F) (K261242)** |
| | Stainless steel reinforcement | Same |
| | Markerband Nylon with Tungsten | Same |
| **- hydrophilic coating composition** | Polyvinylpyrrolidone-based coating | Polyvinylpyrrolidone water-soluble polymer (hydrophilic coating) & primer |
| **DILATOR** | **Dilator Assembly** Tubing: Polypropylene. Hub: Polypropylene/Thermoplastic Elastomer. Blend Coating: Silicone Caulking Pin: Stainless steel. | **Dilator Assembly** Tubing: Pebax 7033 / Bismuth subcarbonate / Zinc stearate. Glue: Acrylate glue. Hub: Polycarbonate |
| **Shelf-life** | 30 months | 36 months |
| **Sterility** | Ethylene Oxide (validated in accordance with ANSI / AAMI / ISO 11135-1 to achieve SAL 10^{-6}) | Same |
| **Packaging** | Unit Pouch; Shelf Box; Shipping Carton | Same |
**Table 2: Comparison Reference Device and Proposed Device**
| | Reference Device | New Proposed Device |
| --- | --- | --- |
| | **Convey Guiding Catheter (7F) (K132197)** ***Primum Hydrophilic Guiding Catheter (K250972)** | **SimplGuide guiding sheath (6F) K261242** |
| **Product Code** | **DQY (Catheter percutaneous)** | **DYB (Introducer, catheter)** |
| **Trade Name** | Convey™ Guiding Catheter *Primum Hydrophilic Guiding Catheter | SimplGuide |
| **Indications for use** | The Convey Guiding/*Primum Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system. | The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site. |
| **Operating Principle** | Operated manually or by a manual process | Same |
| **Design** | Length: 100 cm | Same |
| | ID: 2.08mm | ID: 2.10mm |
| | OD: 2.37mm | OD: 2.48mm |
{8}
Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 5 of 7
| | Reference Device | New Proposed Device |
| --- | --- | --- |
| | **Convey Guiding Catheter (7F) (K132197)** ***Primum Hydrophilic Guiding Catheter (K250972)** | **SimplGuide guiding sheath (6F) K261242** |
| - *design / construction* | Catheter | Sheath, Vessel Dilator |
| - *outer hydrophilic coating* | Yes | Same |
| - *hydrophilic coating length* | Hydrophilic Coating Length: 75cm proximal of the intermediate tip | Hydrophilic Coating: 75cm distal length |
| - *tip configuration* | Only shaped tips | Straight tip |
| - *tip visibility material* | Radiopaque soft tip | Radiopaque Tip: Nylon with Tungsten |
| - *body reinforcement config* | Braided reinforcement | Same |
| - *hub* | Nylon Colorant | Same |
| **Vessel dilator** | No vessel dilator included | Vessel dilator included |
| **Vessel dilator extended length** | N.A. | 5cm |
| **Hemostasis device** | No hemostasis device included | Same |
| **Materials** | Inner layer: PolyAmide/PolyEthylene blend | Same |
| | Outer Layer: Nylon / polyether-blok-amide | Same |
| | Stainless steel reinforcement | Same |
| | Bismuth oxychloride filled marker material | Markerband Nylon with Tungsten |
| - *hydrophilic coating composition* | Polyvinylpyrrolidone PVP water-soluble polymer (hydrophilic coating) & primer | Same |
| **DILATOR** | N/A | **Dilator Assembly** Tubing: Pebax 7033 / Bismuth subcarbonate / Zinc stearate. Glue: Acrylate glue. Hub: Polycarbonate |
| **Shelf-life** | 36 months | Same |
| **Sterility** | Ethylene Oxide (validated in accordance with ANSI / AAMI / ISO 11135-1 to achieve SAL 10^{-6}) | Same |
| **Packaging** | Unit Pouch; Shelf Box; Shipping Carton | Same |
{9}
Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 6 of 7
### H. Summary biocompatibility and bench testing
The following biocompatibility tests were completed on the SimplGuide Guiding Sheath considering the categorization of the Material Characterization for medical application per ISO 10993-1 and USP.
#### ISO 10993-4: Hemocompatibility
- Hemolysis Test (Complete - Direct and Indirect Contact)
- Partial Thromboplastin Time (UPTT) Test – Direct Contact Method
- Complement Activation (C3 Complement Protein) Test – Indirect Contact Method
- Complement Activation (SC5b-9 (C5) Complement Protein) Test – Indirect Contact Method
- Platelet and Leukocyte Count (Direct Contact)
#### ISO 10993-5: Cytotoxicity
- L929 Minimal Essential Medium (MEM) Elution Test
#### ISO 10993-7: Ethylene Oxide Sterilization Residuals
- Simulated use: residue value after 24 hours at 37°C by Gas chromatography.
#### ISO 10993-10: Sensitization
- Kligman Maximization Test – Normal Saline and Vegetable (Cottonseed) Oil Extracts
#### ISO 10993-10: Irritation/ Intracutaneous Reactivity
- Intracutaneous Injection Test – Normal Saline and Vegetable (Cottonseed) Oil Extracts
#### ISO 10993-11: Systemic toxicity
- Systemic Injection Test
#### ISO 10993-18: 2020 /Amd: 2023 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
- Chemical characterization of the materials is performed.
#### ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Test for irritation
- Intracutaneous Injection Test
#### USP <85> Endotoxin-Mediated Pyrogenicity
- LAL test.
The following in-vitro performances tests (following simulated use, if applicable) were completed of the SimplGuide Guiding Sheath:
- Inner Diameter
- Outer Diameter
- Catheter Usable Length
- Coating Length
- C-Kink (Bending Kink Diameter)
- Euler Kink (axial Kink Displacement)
- Radial Stiffness (Collapse)
- Coating Integrity (Visual Inspection)
- Outer Friction & Wear (Coating Integrity – functional tests)
- Three Point Bending Test (ending Stiffness Body)
- Pull Force (after simulated use)
- Radiopacity
- USP <788> Particulate testing (Light Obscuration after simulated use). Particle Count Test
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Traditional 510(k) Notification
PendraCare SimplGuide Guiding Sheath
K261242
Page 7 of 7
### I. Clinical and Nonclinical Performance Data and Conclusions
This 510(k) does not include data from clinical tests.
The User requirements were validated and concluded that it meets the Product Description and design for its intended purpose.
Performance testing was conducted to ensure that the SimplGuide Guiding Sheath met the applicable design and performance requirements during the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
### J. Conclusion
In summary, the PendraCare SimplGuide Guiding Sheath is substantially equivalent to its legally marketed predicate device, the R2P Destination Slender Guiding Sheath (K193125) with respect to the intended use, operating principles, fundamental design, catheter dimension, materials, technology, packaging, labeling and sterility.
