PICC (CT RATED AND NON-RATED)
FDA 510(k) clearance K083873 · decided 2009-03-19
Clearance details
- K-number
- K083873
- Device name
- PICC (CT RATED AND NON-RATED)
- Applicant
- Pfm Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-29
- Decision date
- 2009-03-19
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Oceanside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introduc recall (Z-0563-2015) | Pfm Medical Inc | 2014-12-12 |
| 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is recall (Z-0564-2015) | Pfm Medical Inc | 2014-12-12 |
| ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT P recall (Z-0565-2015) | Pfm Medical Inc | 2014-12-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NIT-OCCLUD PDA (P120009/S004) | Pfm Medical, Inc. | 2024-10-17 |
| PMA NIT-OCCLUD PDA (P120009/S003) | Pfm Medical, Inc. | 2016-12-16 |
| NIT-OCCLUD SYSTEM (P120009/S002) | Pfm Medical, Inc. | 2015-01-21 |
| NIT-OCCLUD PDA (P120009/S001) | Pfm Medical, Inc. | 2014-08-01 |
| NIT-OCCLUD PDA (P120009) | Pfm Medical, Inc. | 2013-08-16 |