510(k) K980734 ยท HRX Arthroscope
MYELOTEC VIDEO GUIDED CATHETER
| Applicant | Myelotec, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 11, 1998 |
| Received | Feb 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2017 | Myelotec, Inc. Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels Open, Classified |
HRX | None listed |
| Apr 10, 2008 | Myelotec, Inc. Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.