ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing— 510(k) K202182
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K202182 for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Substantially Equivalent on 2020-09-02. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Campbell, CA, US
Recent devices under product code NRY
view allMore clearances from Imperative Care, Inc.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K202182
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202182.
Data sourced from openFDA. This site is unofficial and independent of the FDA.