510(k) K935391 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 24, 1994 |
| Received | Nov 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2011 | Terumo Cardiovascular Systems Corporation Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI.
The sternal saw blades are indicated for use in medial sternotomo Terminated |
GFA | None listed |
| Dec 2, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S.
Indicated for use in medial Terminated |
GFA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.