The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central.
| Device ID | K974015 |
| 510k Number | K974015 |
| Device Name: | ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-22 |
| Decision Date | 1998-05-18 |
| Summary: | summary |