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FDA 510(k)

Imperative Care Radial 088 Access System

K-Number: K220807 · 2022-05-17

ApplicantImperative Care, Inc.
Decision Date2022-05-17
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Imperative Care Radial 088 Access System is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2022-05-17 under approval number K220807. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imperative Care Radial 088 Access System?

Imperative Care Radial 088 Access System is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Imperative Care, Inc.. The 510(k) number is K220807.

When was Imperative Care Radial 088 Access System approved by the FDA?

Imperative Care Radial 088 Access System received FDA 510(k) clearance on 2022-05-17, under approval number K220807.

What company makes Imperative Care Radial 088 Access System?

Imperative Care Radial 088 Access System is manufactured by Imperative Care, Inc..

What is the FDA product code for Imperative Care Radial 088 Access System?

The FDA product code for Imperative Care Radial 088 Access System is QJP.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Imperative Care, Inc.

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 Length K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

View all 17 devices →

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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