The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for 11000 Rapture Phased Array Peripheral Vascular Coil.
| Device ID | K042207 |
| 510k Number | K042207 |
| Device Name: | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | James Wrenn |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2004-08-26 |
| Summary: | summary |