Identity
- Trade Name
- Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port EUDAMEDARROW FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- CATH LAB SHEATH INTRO SET EUDAMEDSuper Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI
- Model / Reference
- CL-07700 EUDAMEDIPN921168 FDA UDI
- Description
- Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI
Identifiers
- Catalog Number
- CL-07700 FDA UDI
- Primary DI / UDI-DI
- 10801902201024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10801902201024 EUDAMED
- 510(k) Number
- K924607 FDA UDI
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Vascular catheter introduction set, nonimplantable
Arrow by Teleflex Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
- VYGON — Vygon Corp. · Class II
- OneStic Micro-Access Introducer — Argon Medical Devices, Inc. · Class II
- ClearSheath — Newtech Medical Devices Pvt. Ltd. · Class IIa
- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
- Sterile Catheter Sheath Sets — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Demax — Beijing Demax Medical Technology Co., Ltd. · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd. · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K924607 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI a022e876-1268-4064-b6d6-5cc5e4a203ba 36 fields · synced Oct 7, 2026
- EUDAMED 5cb4aaa5-c1c8-46c7-888f-64d3a71598c5 61 fields · synced Oct 7, 2026