Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intra-aortic balloon catheter FDA UDI
- Device Name
- UltraFlex(TM) IAB FDA UDI
- Model / Reference
- IPN915321 FDA UDI
- Description
- UltraFlex(TM) IAB FDA UDI
Identifiers
- Catalog Number
- IAB-06830-U FDA UDI
- Primary DI / UDI-DI
- 10801902161939 FDA UDI
- 510(k) Number
- K000729 FDA UDI
- FDA Product Code
- DSP FDA UDI
- GMDN Term
- Intra-aortic balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3535 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 30 Milliliter FDA UDI
Category: Intra-aortic balloon catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intra-aortic balloon catheter.
- Ultra IABP Catheter Kit — INSIGHTRA MEDICAL, INC. · Class II
- MEGA 7.5 Fr. 30cc IAB W/O Statlock - INDIA — Datascope Corp. · Class II
- MEGA 7.5Fr. 40cc IAB with Accessories, US Only — Datascope Corp. · Class II
- TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES — Datascope Corp. · Class II
- Linear 7.5Fr. 25cc IAB — Datascope Corp. · Class II
- MEGA 8Fr. 50cc IAB (W/O Statlock) — Datascope Corp. · Class II
- SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) — Datascope Corp. · Class II
- MEGA 7.5 Fr. 40cc IAB (China) — Datascope Corp. · Class II
Cleared under the same submission
K000729 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 (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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 29310c6e-bcd0-4eee-95da-0a7b4faaec5a 37 fields · synced Jun 1, 2026