The following data is part of a premarket notification filed by Endophys, Inc. with the FDA for Endophys Pressure Sensing Sheath Kit.
| Device ID | K141275 |
| 510k Number | K141275 |
| Device Name: | ENDOPHYS PRESSURE SENSING SHEATH KIT |
| Classification | Introducer, Catheter |
| Applicant | ENDOPHYS, INC. 755 N. MATHILDA, AVE. SUITE 100 Sunnyvale, CA 94085 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren ENDOPHYS, INC. 755 N. MATHILDA, AVE. SUITE 100 Sunnyvale, CA 94085 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-16 |
| Decision Date | 2015-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852004007024 | K141275 | 000 |
| 00852004007017 | K141275 | 000 |