The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Mahurkar 13.5 Fr Cuffed Catheter With Curved Extensions.
| Device ID | K981365 |
| 510k Number | K981365 |
| Device Name: | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SHERWOOD MEDICAL CO. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Rosemary Harry |
| Correspondent | Rosemary Harry SHERWOOD MEDICAL CO. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-15 |
| Decision Date | 1998-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521070448 | K981365 | 000 |
| 10884521070417 | K981365 | 000 |
| 10884521012417 | K981365 | 000 |
| 10884521012400 | K981365 | 000 |
| 10884521012394 | K981365 | 000 |
| 10884521012011 | K981365 | 000 |