The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Medtronic Ps Medical Bioglide Vascular Catheter, Sngl Lumen Model Nos 8960 & 8932.
| Device ID | K960055 |
| 510k Number | K960055 |
| Device Name: | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIV BUSINESS CTR. 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIV BUSINESS CTR. 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 | 1996-01-04 |
| Decision Date | 1996-09-30 |
| Summary: | summary |