Chrysalis Intelligence · Sponsors · Imperative Care, Inc.

Imperative Care, Inc.

Campbell, CA, US · 15 510(k) clearances · 1 recalls (1 Class I)

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
15
2020-09-02 → 2025-10-30
Last 12 months
2
Product codes
5
Most recent
2025-10-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NRY Catheter, Thrombus Retriever Class II Cardiovascular 6 2025-10-30
QJP — — — 5 2024-06-06
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 2 2025-08-28
MOF — — — 1 2025-08-26
DQO — — — 1 2024-04-02
Safety

Recalls (1)

Class I (serious)
1
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2021-08-13
DateSeverityStatusRecall # ProductCodeReason
2021-08-13 Class I Completed Z-2577-2021 Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm),… — There is a potential for distal end of catheters to fracture and become detached.
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2025-10-30 K252046 Zoom System (Zoom 4S Catheter) NRY Class II Cardiovascular
2025-08-28 K252057 Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System QEW Class II Cardiovascular
2025-08-26 K244061 X-Wire Guidewire MOF — —
2025-05-28 K243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing NRY Class II Cardiovascular
2025-05-14 K250775 Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System QEW Class II Cardiovascular
2025-01-14 K242672 Zoom System NRY Class II Cardiovascular
2024-06-06 K240948 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support QJP — —
2024-04-02 K233975 Zoom 6F Insert Catheters DQO — —
2023-05-22 K231168 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support QJP — —
2022-05-17 K220807 Imperative Care Radial 088 Access System QJP — —
2021-09-20 K212224 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform QJP — —
2021-06-08 K211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing NRY Class II Cardiovascular
2021-04-23 K210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing NRY Class II Cardiovascular
2021-03-03 K203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform QJP — —
2020-09-02 K202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing NRY Class II Cardiovascular
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence