The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Protectiv 2000 I.v. Catheter Safety System.
| Device ID | K962226 |
| 510k Number | K962226 |
| Device Name: | PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-10 |
| Decision Date | 1996-12-23 |
| Summary: | summary |