The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Double Lumen Picc.
Device ID | K970926 |
510k Number | K970926 |
Device Name: | DOUBLE LUMEN PICC |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Contact | Mark S Alsberge |
Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-13 |
Decision Date | 1997-08-01 |