The following data is part of a premarket notification filed by Zurich Medical Inc. with the FDA for Zurich Pressure Guidewire System Model 100.
| Device ID | K190852 |
| 510k Number | K190852 |
| Device Name: | Zurich Pressure Guidewire System Model 100 |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Zurich Medical Inc. 2405 Xenium Lane N Plymouth, MN 55441 |
| Contact | Kin-joe Sham |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXO |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-02 |
| Decision Date | 2019-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022994081 | K190852 | 000 |
| 00850022994111 | K190852 | 000 |
| 00850022994104 | K190852 | 000 |
| 00850022994098 | K190852 | 000 |
| 00850022994357 | K190852 | 000 |
| 00850022994340 | K190852 | 000 |
| 00850022994333 | K190852 | 000 |
| 00850022994326 | K190852 | 000 |
| 00850022994296 | K190852 | 000 |
| 00850022994289 | K190852 | 000 |
| 00850022994272 | K190852 | 000 |
| 00850022994128 | K190852 | 000 |
| 00850022994142 | K190852 | 000 |
| 00850022994159 | K190852 | 000 |
| 00850022994074 | K190852 | 000 |
| 00850022994067 | K190852 | 000 |
| 00850022994050 | K190852 | 000 |
| 00850022994043 | K190852 | 000 |
| 00850022994036 | K190852 | 000 |
| 00850022994029 | K190852 | 000 |
| 00850022994012 | K190852 | 000 |
| 00850022994005 | K190852 | 000 |
| 00850022994173 | K190852 | 000 |
| 00850022994166 | K190852 | 000 |
| 00850022994265 | K190852 | 000 |