The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Ccentermark Catheter Introducer Shealth With Protectiv 2000 Needle Safety System.
| Device ID | K962978 |
| 510k Number | K962978 |
| Device Name: | CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 1350 WILLOW RD. Menlo Park, CA 94025 |
| Contact | Phyllis Elson |
| Correspondent | Phyllis Elson JOHNSON & JOHNSON MEDICAL, INC. 1350 WILLOW RD. Menlo Park, CA 94025 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1997-01-07 |
| Summary: | summary |