FDA 510(k)

SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE

K-Number: K872472 · 1987-09-14

Decision Date1987-09-14

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Angiomedics, Inc.. It received FDA 510(k) clearance on 1987-09-14 under 510(k) number K872472. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE?

SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Angiomedics, Inc.. The 510(k) number is K872472.

When did SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE receive FDA 510(k) clearance?

SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE received FDA 510(k) clearance on 1987-09-14, under 510(k) number K872472.

Who is the listed applicant for SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE?

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

What is the FDA product code for SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE?

The FDA product code for SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE is DXT.

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Other records listing Angiomedics, Inc. as applicant

K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO K872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER K863342SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER K861238ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV K852872ANGIOMEDICS SOFTIP CATHETER K850271ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

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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.