The following data is part of a premarket notification filed by Merit Medical Systems Inc. with the FDA for Prelude Plastic Jacketed Guide Wire.
| Device ID | K142051 |
| 510k Number | K142051 |
| Device Name: | PRELUDE PLASTIC JACKETED GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Contact | Michael O'sullivan |
| Correspondent | Michael O'sullivan MERIT MEDICAL SYSTEMS INC. PARKMORE BUSINESS PARK WEST Galway, IE Ei |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450208278 | K142051 | 000 |
| 20884450208261 | K142051 | 000 |
| 20884450208254 | K142051 | 000 |
| 20884450208247 | K142051 | 000 |