510(k) K201595 ยท DQX Wire, Guide, Catheter
Merit Hydrophilic Guide Wire
| Applicant | Merit Medical Systems, Inc., Galway, IE |
| Decision | Substantially Equivalent, Oct 14, 2020 |
| Received | Jun 12, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Merit Medical Systems, Inc. Splashwire Hydrophilic Guide Wire:
REF: MSWSTDA35150
UDI-DI codes:
00884450529645
00884450529669
00884450529690
REF: MSWSTDA35180
UDI-DI codes:
00884450529645
00884450529669
REF: MSWSTDA35260EX
UDI- Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.