510(k) K962572 ยท DQX Wire, Guide, Catheter
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
| Applicant | Scimed Life Systems, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Dec 17, 1996 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2003 | Symbiosis Corp. Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is s Terminated |
DQX | None listed |
| Feb 27, 2003 | Symbiosis Corp. Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length. Terminated |
DQX | None listed |
| Feb 27, 2003 | Symbiosis Corp. Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) proce Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.