The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ipi Algo-line Catheter.
| Device ID | K911382 |
| 510k Number | K911382 |
| Device Name: | IPI ALGO-LINE CATHETER |
| Classification | Catheter, Percutaneous, Intraspinal, Short Term |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Product Code | MAJ |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994840295 | K911382 | 000 |
| 00763000031268 | K911382 | 000 |
| 00763000027841 | K911382 | 000 |
| 00763000027858 | K911382 | 000 |
| 00763000031404 | K911382 | 000 |
| 00763000031411 | K911382 | 000 |
| 00673978226828 | K911382 | 000 |
| 00673978226835 | K911382 | 000 |
| 00673978226842 | K911382 | 000 |
| 00673978226859 | K911382 | 000 |
| 00673978230436 | K911382 | 000 |
| 00673978230467 | K911382 | 000 |
| 00643169466319 | K911382 | 000 |
| 00643169466326 | K911382 | 000 |
| 00763000031251 | K911382 | 000 |