The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Neo-sert.
| Device ID | K942564 |
| 510k Number | K942564 |
| Device Name: | ARGYLE NEO-SERT |
| Classification | Catheter, Umbilical Artery |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884527020553 | K942564 | 000 |
| 10884527020546 | K942564 | 000 |
| 20884527005229 | K942564 | 000 |
| 20884527005212 | K942564 | 000 |