The following data is part of a premarket notification filed by Distal Access, Llc with the FDA for Distal Access Torque Device.
| Device ID | K141054 |
| 510k Number | K141054 |
| Device Name: | DISTAL ACCESS TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | DISTAL ACCESS, LLC 5010 HUEGA COURT Park City, UT 84098 |
| Contact | Carol Stamp |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450277246 | K141054 | 000 |
| 10884450277222 | K141054 | 000 |
| B0905XGW1 | K141054 | 000 |
| B090SPN10051 | K141054 | 000 |