Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

K-Number: K211476 · 2021-06-08

ApplicantImperative Care, Inc.
Decision Date2021-06-08
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2021-06-08 under approval number K211476. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing?

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2021-06-08. It is manufactured by Imperative Care, Inc.. The 510(k) number is K211476.

When was ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing approved by the FDA?

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing received FDA 510(k) clearance on 2021-06-08, under approval number K211476.

What company makes ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing?

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is manufactured by Imperative Care, Inc..

What is the FDA product code for ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing?

The FDA product code for ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is NRY.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT06034847 Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy WITHDRAWN NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED

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 K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

View all 17 devices →

Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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.

↑