The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato Medical Infuse-a-port/infuse-a-kit Periport Peripheral Access System.
| Device ID | K934518 |
| 510k Number | K934518 |
| Device Name: | STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | J. Christopher Flaherty |
| Correspondent | J. Christopher Flaherty STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-17 |
| Decision Date | 1995-01-27 |