The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Peripherally Inserted Central.
| Device ID | K971999 |
| 510k Number | K971999 |
| Device Name: | PERIPHERALLY INSERTED CENTRAL |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. P.O. BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. P.O. BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-11-24 |
| Summary: | summary |