The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Cardiovascular Pressure Measurement (cpm) System, Navvus Catheter.
Device ID | K132474 |
510k Number | K132474 |
Device Name: | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie, MN 55344 |
Contact | Matthew Stepanek |
Correspondent | Matthew Stepanek ACIST MEDICAL SYSTEMS 7905 FULLER ROAD Eden Prairie, MN 55344 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-07 |
Decision Date | 2014-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30841716102845 | K132474 | 000 |
30841716100483 | K132474 | 000 |
30841716100490 | K132474 | 000 |
30841716100506 | K132474 | 000 |
30841716100513 | K132474 | 000 |
30841716100520 | K132474 | 000 |
30841716100537 | K132474 | 000 |
30841716100544 | K132474 | 000 |
30841716100551 | K132474 | 000 |
30841716100476 | K132474 | 000 |
30841716100469 | K132474 | 000 |
30841716100452 | K132474 | 000 |
30841716100360 | K132474 | 000 |
30841716100377 | K132474 | 000 |
30841716100391 | K132474 | 000 |
30841716100407 | K132474 | 000 |
30841716100414 | K132474 | 000 |
30841716100421 | K132474 | 000 |
30841716100438 | K132474 | 000 |
30841716100445 | K132474 | 000 |
30841716100568 | K132474 | 000 |
30841716100575 | K132474 | 000 |
30841716102067 | K132474 | 000 |
30841716102074 | K132474 | 000 |
30841716102180 | K132474 | 000 |
40841716100664 | K132474 | 000 |
40841716100671 | K132474 | 000 |
40841716100688 | K132474 | 000 |
40841716100732 | K132474 | 000 |
40841716100763 | K132474 | 000 |
30841716102012 | K132474 | 000 |
30841716101725 | K132474 | 000 |
30841716101718 | K132474 | 000 |
30841716101459 | K132474 | 000 |
30841716101466 | K132474 | 000 |
30841716101473 | K132474 | 000 |
30841716101480 | K132474 | 000 |
30841716101497 | K132474 | 000 |
30841716101503 | K132474 | 000 |
30841716101510 | K132474 | 000 |
30841716101701 | K132474 | 000 |
40841716101746 | K132474 | 000 |