The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Ipi Vascular Access Catheter.
| Device ID | K954409 |
| 510k Number | K954409 |
| Device Name: | PS MEDICAL IPI VASCULAR ACCESS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-20 |
| Decision Date | 1995-12-18 |