The following data is part of a premarket notification filed by Jomed, Inc. with the FDA for Smartwire/smartmap Pressure System.
| Device ID | K021219 |
| 510k Number | K021219 |
| Device Name: | SMARTWIRE/SMARTMAP PRESSURE SYSTEM |
| Classification | Wire, Guide, Catheter |
| Applicant | JOMED, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Terry Schultz |
| Correspondent | Terry Schultz JOMED, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2002-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012731 | K021219 | 000 |