Data / Medical devices / United States / Imperative Care Inc.

Imperative Care Inc.: FDA-registered device maker in Campbell, CA, United States, 20 510(k) clearances

Name: Imperative Care Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Imperative Care Inc. is registered with the FDA (registration 3014590708) in Campbell, CA, United States. It lists 8 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 28, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014590708
Address: 1359 Dell Ave, Campbell, CA, United States, 95008
Owner or operator: Imperative Care Inc. (10058493)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 4, 2018
Registered through: 2026
Brand names listed: Ikon Guidewire, Imperative Care, Inc. Prodigy Thrombectomy System, Imperative Care, Inc. Symphony Thrombectomy System, Symphony 16F 82cm Thrombectomy System, Symphony Thrombectomy System, TRUVIC Medical Inc. Symphony Thrombectomy System, TRX Long Sheath, TracStar LDP Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 28, 2026	K261176	Zoom 4S Catheter	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
October 30, 2025	K252046	Zoom System (Zoom 4S Catheter)	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
August 28, 2025	K252057	Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System	QEW	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
August 26, 2025	K244061	X-Wire Guidewire	MOF	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
May 28, 2025	K243047	Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
May 14, 2025	K250775	Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System	QEW	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
January 14, 2025	K242672	Zoom System	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
June 6, 2024	K240948	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
April 2, 2024	K233975	Zoom 6F Insert Catheters	DQO	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
May 22, 2023	K231168	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
February 23, 2023	K223216	Symphony Thrombectomy System	QEW	Substantially Equivalent	Truvic Medical, Inc.	accessdata.fda.gov
May 17, 2022	K220807	Imperative Care Radial 088 Access System	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
April 6, 2022	K214114	Prodigy Thrombectomy System	QEW	Substantially Equivalent	Truvic Medical, Inc.	accessdata.fda.gov
September 20, 2021	K212224	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
June 8, 2021	K211476	ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
April 23, 2021	K210996	ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
March 3, 2021	K203764	TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform	QJP	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
September 2, 2020	K202182	ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
April 17, 2019	K183043	0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter	NRY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov
August 8, 2018	K180169	EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length	DQY	Substantially Equivalent	Imperative Care, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 13, 2021	88611	Class I	Completed	Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm),.071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.	There is a potential for distal end of catheters to fracture and become detached.	accessdata.fda.gov

Compare with other makers

Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.