The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cvp Polyurethane Catheter.
| Device ID | K961552 |
| 510k Number | K961552 |
| Device Name: | CVP POLYURETHANE CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ABBOTT LABORATORIES DEPT. 389, AP30 Abbott Park, IL 60064 -3537 |
| Contact | David Guzek |
| Correspondent | David Guzek ABBOTT LABORATORIES DEPT. 389, AP30 Abbott Park, IL 60064 -3537 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1997-02-10 |