Chrysalis Intelligence · Sponsors · Imperative Care, Inc.

Imperative Care, Inc.

Campbell, CA, US · 16 510(k) clearances · 1 recalls (1 Class I)

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Total clearances

16

2020-09-02 → 2026-08-28

Last 12 months

2

Product codes

5

Most recent

2026-08-28

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QJP	Catheter, Percutaneous, Neurovasculature	Class II	Cardiovascular	6	2026-08-28
NRY	Catheter, Thrombus Retriever	Class II	Cardiovascular	6	2025-10-30
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class II	Cardiovascular	2	2025-08-28
MOF	Guide, Wire, Catheter, Neurovasculature	Class II	Cardiovascular	1	2025-08-26
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	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

Date	Severity	Status	Recall #	Product	Code	Reason
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 (16)

Date	K-number	Device	Code	Class	Specialty
2026-08-28	K261176	Zoom 4S Catheter	QJP	Class II	Cardiovascular
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	Class II	Cardiovascular
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	Class II	Cardiovascular
2024-04-02	K233975	Zoom 6F Insert Catheters	DQO	Class II	Cardiovascular
2023-05-22	K231168	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support	QJP	Class II	Cardiovascular
2022-05-17	K220807	Imperative Care Radial 088 Access System	QJP	Class II	Cardiovascular
2021-09-20	K212224	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform	QJP	Class II	Cardiovascular
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	Class II	Cardiovascular
2020-09-02	K202182	ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	NRY	Class II	Cardiovascular