primePICC PFM2CT4SP
primePICC PFM2CT4SP is a peripherally-inserted central venous catheter (FDA Class II; FDA product code LJS, Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days) made by Pfm Medical Incorporated, cleared under FDA 510(k) K083873 on 19 Mar 2009 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 00813623010178), active as of 22 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813623010178 | Date31 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083873 | Date19 Mar 2009 | StatusActive |
Official records
- AccessGUDID record 00813623010178
- FDA 510(k) database K083873
Across registries
- FDA 510(k) K083873 decided 19 Mar 2009 Active
- FDA GUDID UDI-DI 00813623010178 listed 31 Jul 2019 Listed
Recalls
-
- Terminated Z-0563-2015
- Terminated Z-0564-2015
- Terminated Z-0565-2015
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Timeline
- Cleared FDA 510(k) K083873
- Recall initiated FDA recalls Z-0563-2015
- Recall initiated FDA recalls Z-0564-2015
- Recall initiated FDA recalls Z-0565-2015
- Listed FDA GUDID 00813623010178
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- primePICC
- Generic name
- Peripherally-inserted central venous catheter
- Model / reference
- PFM2CT4SP
- Primary DI / UDI-DI
- 00813623010178
- 510(k) Number
- FDA product code
- LJS
- GMDN term
- Peripherally-inserted central venous catheter
- Device class
- Class II
- Regulation number
- 880.5970
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Peripherally-inserted central venous catheter.