The following data is part of a premarket notification filed by Summit Access, Llc with the FDA for Microtaper Needle Introducer Set.
| Device ID | K151076 |
| 510k Number | K151076 |
| Device Name: | MicroTaper Needle Introducer Set |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Summit Access, LLC 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 |
| Contact | Fred Piazza |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860327000251 | K151076 | 000 |
| 20860327000244 | K151076 | 000 |
| 20860327000237 | K151076 | 000 |
| 20860327000220 | K151076 | 000 |
| 20860327000213 | K151076 | 000 |