The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Vesseloops.
| Device ID | K905240 |
| 510k Number | K905240 |
| Device Name: | VESSELOOPS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Contact | Carleton F Kimber |
| Correspondent | Carleton F Kimber SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-02-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VESSELOOPS 74471299 not registered Dead/Abandoned |
MAXXIM MEDICAL CORPORATION 1993-12-20 |
![]() VESSELOOPS 72423303 0973493 Live/Registered |
MED GENERAL, INC. 1972-05-04 |