510(k) clearance
Zoom 4S Catheter
- 510(k) number
- K261176
- Applicant
- Imperative Care, Inc.
- Decision date
- Aug 28, 2026
- Date received
- Apr 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QJP
- Device type
- Catheter, Percutaneous, Neurovasculature
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Campbell, CA, US