510(k) K190473
- Device
- ACIST RXi System And Navvus II Catheter
- Applicant
- ACIST Medical Systems, Inc.
- 510(k) number
- K190473
- Product code
- OBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-13
- Date received
- 2019-02-27
- Regulation
- 870.1200
- Classification name
- Catheter, Pressure Monitoring, Cardiac
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sherri Mellingen
- Address
- 7905 Fuller Rd. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 1222140
- 2134243
- 2011171
Source Documents#
Legacy Summary#
summary
FDA Review#
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