The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Modified Pruitt Irrigation & Occlusion Catheter.
| Device ID | K880231 |
| 510k Number | K880231 |
| Device Name: | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER |
| Classification | Occluder, Catheter Tip |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663101542 | K880231 | 000 |
| 00840663101535 | K880231 | 000 |