The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle(r) Hydrophilic Coated Thoracic Catheter.
| Device ID | K950201 |
| 510k Number | K950201 |
| Device Name: | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER |
| Classification | Catheter And Tip, Suction |
| 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 | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-12-15 |