The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Infuse-a-cath Silicone Central Venous Catheter.
| Device ID | K921751 |
| 510k Number | K921751 |
| Device Name: | INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | Frederick J Marano |
| Correspondent | Frederick J Marano STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1993-07-07 |