The following data is part of a premarket notification filed by Summit Medical Products, Inc with the FDA for Ambit Introducer, Ambit Needle, Ambit Sheath.
| Device ID | K102460 |
| 510k Number | K102460 |
| Device Name: | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | SUMMIT MEDICAL PRODUCTS, INC 2480 SOUTH MAIN STREET Salt Lake City, UT 84115 |
| Contact | Marko Van Amen |
| Correspondent | Marko Van Amen SUMMIT MEDICAL PRODUCTS, INC 2480 SOUTH MAIN STREET Salt Lake City, UT 84115 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193494000619 | K102460 | 000 |