510(k) K211405 ยท DYB Introducer, Catheter
Prelude Guide Sheath
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Oct 4, 2021 |
| Received | May 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2024 | Merit Medical Systems, Inc. Prelude Roadster Guide Sheath REF:
-PG4F45S
-PG4F90S
-PG5F45MP
-PG5F45R
-PG5F45S
-PG5F45S018
-PG5F90MP
-PG5F90S
-PG5F90S018
-PG6F45HS
-PG6F45MP
-PG6F45R
-PG6F45S
-PG6F45S018
-PG6F65MP
-PG6F65S
-PG6F65 Open, Classified |
DYB | None listed |
| May 20, 2024 | Merit Medical Systems, Inc. Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY Open, Classified |
DYB | None listed |
| May 20, 2024 | Merit Medical Systems, Inc. Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.