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FDA 510(k)

KEY VASCULAR BOOTIES

K-Number: K896472 · 1989-12-14

ApplicantKey Surgical, Inc.
Decision Date1989-12-14
Product CodeMAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEY VASCULAR BOOTIES is the device name listed in this FDA 510(k) record. The listed applicant is Key Surgical, Inc.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K896472. The device is classified under product code MAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEY VASCULAR BOOTIES?

KEY VASCULAR BOOTIES is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Key Surgical, Inc.. The 510(k) number is K896472.

When did KEY VASCULAR BOOTIES receive FDA 510(k) clearance?

KEY VASCULAR BOOTIES received FDA 510(k) clearance on 1989-12-14, under 510(k) number K896472.

Who is the listed applicant for KEY VASCULAR BOOTIES?

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

What is the FDA product code for KEY VASCULAR BOOTIES?

The FDA product code for KEY VASCULAR BOOTIES is MAW.

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 Key Surgical, Inc. 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.

K910328KEY COMFORT GRIPSK896676KEY VASCULAR LOOPSK895591SILICONE INSTRUMENT SHODS

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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