The following data is part of a premarket notification filed by Mediguide, Ltd. with the FDA for Guided Measurement Catheter (gmc).
| Device ID | K091780 |
| 510k Number | K091780 |
| Device Name: | GUIDED MEASUREMENT CATHETER (GMC) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MEDIGUIDE, LTD. 555 THIRTEENTH ST NW COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDIGUIDE, LTD. 555 THIRTEENTH ST NW COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-10-16 |
| Summary: | summary |