510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Imperative Care Inc.

Campbell, CA, US

IMPERATIVE CARE INC. appears in FDA device records in Campbell, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Imperative Care Inc. between 2018 and 2025. The busiest year on record is 2025, with 6. The most recent is 2025, with 6.

Clearances by year, as a table
510(k) clearance decisions for Imperative Care Inc., by decision year
YearClearances
20181
20191
20201
20214
20221
20231
20242
20256
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252046Zoom System (Zoom 4S Catheter)NRYSubstantially Equivalent
K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemQEWSubstantially Equivalent
K244061X-Wire GuidewireMOFSubstantially Equivalent
K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRYSubstantially Equivalent
K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemQEWSubstantially Equivalent
K242672Zoom SystemNRYSubstantially Equivalent
K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportQJPSubstantially Equivalent
K233975Zoom 6F Insert CathetersDQOSubstantially Equivalent
K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportQJPSubstantially Equivalent
K220807Imperative Care Radial 088 Access SystemQJPSubstantially Equivalent
K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformQJPSubstantially Equivalent
K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingNRYSubstantially Equivalent
K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRYSubstantially Equivalent
K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal PlatformQJPSubstantially Equivalent
K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRYSubstantially Equivalent
K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion CatheterNRYSubstantially Equivalent
K180169EagleRay 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 LengthDQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Imperative Care Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30145907083014590708IMPERATIVE CARE INC.1359 Dell Ave, Campbell, CA 95008 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2577-2021Imperative 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.Class ICompleted

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain