The following data is part of a premarket notification filed by Klein-baker Medical, Inc. with the FDA for Neo-picc.
| Device ID | K970434 |
| 510k Number | K970434 |
| Device Name: | NEO-PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-05 |
| Decision Date | 1997-04-01 |