Identity
- Trade Name
- BeBack Crossing Catheter FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm. FDA UDI
- Model / Reference
- 4 F, 120 cm FDA UDI
- Description
- The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm. FDA UDI
Identifiers
- Catalog Number
- GB-600-US-018P-120L FDA UDI
- Primary DI / UDI-DI
- 04260279096487 FDA UDI
- 510(k) Number
- K211802 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Introducer Sheath Compatibility — 4 French FDA UDICatheter Length — 120 Centimeter FDA UDI
Category: Peripheral vascular intervention infusion catheter
BeBack Crossing Catheter by Bentley InnoMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular intervention infusion catheter.
- UniFuse — ANGIODYNAMICS, INC · Class II
- Seamless™ — B. BRAUN MEDICAL INC. · Class II
- PowerMidline — Bard Access Systems, Inc. · Class II
- Seamless™ — B. BRAUN MEDICAL INC. · Class II
- Cragg McNamaraTM — Micro Therapeutics, Inc. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Introcan Safety ® 2 — B. BRAUN MEDICAL INC. · Class II
- Fountain® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Bentley InnoMed GmbH
Sources (1)
- FDA UDI 1ad5c69c-498d-4967-8550-36f46bd4be6f 38 fields · synced May 30, 2026