The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Ostial Pro Stent Positioning System.
| Device ID | K122089 |
| 510k Number | K122089 |
| Device Name: | OSTIAL PRO STENT POSITIONING SYSTEM |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas 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 | 2012-07-16 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450109448 | K122089 | 000 |