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FDA 510(k)

MDS IMAGER

K-Number: K801027 · 1980-05-28

ApplicantMedtronic Vascular
Decision Date1980-05-28
Product Code
DecisionSubstantially Equivalent

Device Summary

MDS IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801027. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDS IMAGER?

MDS IMAGER is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Medtronic Vascular. The 510(k) number is K801027.

When did MDS IMAGER receive FDA 510(k) clearance?

MDS IMAGER received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801027.

Who is the listed applicant for MDS IMAGER?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Medtronic Vascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232570Steerant™ Super Stiff GuidewireK2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterK2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding CatheterK173515Admiral Xtreme

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Official Source

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

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