The following data is part of a premarket notification filed by Surgi-vision, Inc. with the FDA for Intercept Esophageal Internal Mr Coil, Intercept Urethral Internal Mr Coil, And Intercept Vascular Internal Mr Coil.
| Device ID | K020495 |
| 510k Number | K020495 |
| Device Name: | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SURGI-VISION, INC. 20 FIRSTFIELD RD. SUITE 200 Gaithersburg, MD 20878 |
| Contact | Nancy E Taylor |
| Correspondent | Nancy E Taylor SURGI-VISION, INC. 20 FIRSTFIELD RD. SUITE 200 Gaithersburg, MD 20878 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-14 |
| Decision Date | 2002-04-23 |
| Summary: | summary |