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FDA 510(k)

CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE

K-Number: K884481 · 1989-01-10

ApplicantMallinckroot, Inc.
Decision Date1989-01-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckroot, Inc.. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K884481. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE?

CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Mallinckroot, Inc.. The 510(k) number is K884481.

When did CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE receive FDA 510(k) clearance?

CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE received FDA 510(k) clearance on 1989-01-10, under 510(k) number K884481.

Who is the listed applicant for CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE?

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

What is the FDA product code for CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE?

The FDA product code for CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE is LIT.

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Other records listing Mallinckroot, Inc. as applicant

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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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