POWERWAND™ XL 5Fr X 10cm Bifurcated
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10859821006534 | Date31 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131300 | Date7 Jun 2013 | StatusActive |
Recalls
-
- Terminated Z-2254-2013
Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Powerwand™ Xl
- Generic name
- Peripheral vascular catheter
- Model / Ref / Catalog
- 5Fr X 10cm Bifurcated, 94119
- Primary DI / UDI-DI
- 10859821006534
- 510(k) Number
- FDA product code
- DYB
- GMDN term
- Peripheral vascular catheter
- Device class
- Class II
- Regulation number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 10 CentimeterCatheter Gauge — 5 French
Other devices from ICU Medical, Inc.
Properties
Other properties (9)
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No