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510(k) K203764

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform by Imperative Care, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2021
Date Received
December 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Neurovasculature
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other clearances by Imperative Care, Inc.

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  • K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (May 28, 2025)
  • K250775 — Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (May 14, 2025)
  • K242672 — Zoom System (January 14, 2025)
  • K240948 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large (June 6, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K231168 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large (May 22, 2023)
  • K220807 — Imperative Care Radial 088 Access System (May 17, 2022)

Other clearances for product code QJP

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  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)