The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Inqwire Diagnostic Guide Wire.
| Device ID | K002289 |
| 510k Number | K002289 |
| Device Name: | INQWIRE DIAGNOSTIC GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2000-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450094604 | K002289 | 000 |
| 10884450094478 | K002289 | 000 |
| 10884450085315 | K002289 | 000 |
| 10884450056537 | K002289 | 000 |