The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Wigness-buchwald Central Venous Access Catheter.
| Device ID | K895543 |
| 510k Number | K895543 |
| Device Name: | WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS 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 | Joseph Ress |
| Correspondent | Joseph Ress STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-13 |
| Decision Date | 1990-09-21 |