FDA 510(k)

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:

K-Number: K964813 · 1997-02-26

Decision Date1997-02-26

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: is the device name listed in this FDA 510(k) record. The listed applicant is Medical Advances, Inc.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K964813. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Medical Advances, Inc.. The 510(k) number is K964813.

When did MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: receive FDA 510(k) clearance?

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: received FDA 510(k) clearance on 1997-02-26, under 510(k) number K964813.

Who is the listed applicant for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

The FDA 510(k) record lists Medical Advances, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

The FDA product code for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: is MOS.

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Other records listing Medical Advances, Inc. as applicant

K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL K021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL K011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL K010074MODEL 455GE PHASED ARRAY WRIST COIL K003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL K003144MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL

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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.