PERIPHERALLY INSERTED CENTRAL CATHETER
FDA 510(k) clearance K964929 · decided 1997-06-02
Clearance details
- K-number
- K964929
- Device name
- PERIPHERALLY INSERTED CENTRAL CATHETER
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-09
- Decision date
- 1997-06-02
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/ recall (Z-1062-05) | B. Braun Medical, Inc. | 2005-08-03 |
| CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0322-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-01-10 |