Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014590708

FEI Number

3014590708

Entity Name

IMPERATIVE CARE INC.

City/State/Country

Campbell, CA, US

Establishment Address

1359 Dell Ave, Campbell, CA 95008, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Imperative Care Inc. (Owner Number: 10058493)

Owner / Operator Contact Address

1359 Dell Ave, Campbell, CA 95008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240948

PMA Number

N/A

All Registered Proprietary Names

Zoom 88 Large Distal Platform Zoom 88 Large Distal Platform Support Zoom (71, 55, 45, 35) Catheters Zoom POD Aspiration Tubing TracStar LDP Large Distal Platform Zoom Aspiration Tubing Zoom System Zoom Reperfusion Catheter Symphony Thrombectomy System ZOOM Aspiration Tubing ZOOM Reperfusion Catheter ZOOM Aspiration Catheter Ikon Guidewire X-Wire Guidewire ZOOM Reperfusion Catheter ZOOM Aspiration Tubing Zoom 88 LDP Catheter TracStar LDP Catheter Zoom System (Zoom 4S Catheter) Zoom 6F Insert Catheters Zoom 88 LDP Support Catheter TracStar LDP Catheter Zoom 88 LDP Catheter Truvic Medical Inc. Prodigy Thrombectomy System Imperative Care, Inc. Prodigy Thrombectomy System TRX Long Sheath TracStar Large Distal Platform ZOOM 88 Large Distal Platform ZOOM 88-T Large Distal Platform Zoom RDL Radial Access System Zoom Reperfusion Catheter Zoom Aspiration Tubing Symphony 16F 82cm Thrombectomy System Symphony Thrombectomy System ZOOM 88 Large Distal Platform ZOOM 88-T Large Distal Platform TracStar Large Distal Platform Zoom 88 Large Distal Platform TracStar LDP Large Distal Platform Zoom 88 Support Large Distal Platform

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-01-27
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-06-21
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2025-06-10
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2025-06-10
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2020-09-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-09-08
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-09-08
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-04-30
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-09-20
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-09-20
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-11-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-04-22
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-05-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-05-25
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2023-12-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-10-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-08-08
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-08-08
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-06-21
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2025-09-02
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2025-09-02
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-06-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-06-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-12-30
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-12-30

Official Correspondent

Michael Wong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Imperative Care Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11
K241362	Surmodics,Inc.	Pounce XL Thrombectomy System (PTS-1011-7F135)	2024-09-11
K220887	Inari Medical	Mini-ClotTriever Thrombectomy System	2022-08-04
K250421	Inari Medical, Inc.	InThrill Thrombectomy System	2025-05-12
K192036	Inari Medical	ClotTriever Thrombectomy System	2019-08-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014590708. Last updated year: 2026. Please use registration number 3014590708 when referencing this establishment in official correspondence.