The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Hr Polyurethane Picc And Midline Catheters.
| Device ID | K964556 |
| 510k Number | K964556 |
| Device Name: | HR POLYURETHANE PICC AND MIDLINE CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1997-04-16 |
| Summary: | summary |