ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing— 510(k) K210996
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K210996 for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Substantially Equivalent on 2021-04-23. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Product 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 all- K262021 — Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- K263266 — Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
More 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 K210996
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 K210996.
Data sourced from openFDA. This site is unofficial and independent of the FDA.