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FDA 510(k)

ROTARY VASCULAR KNIFE

K-Number: K833547 · 1984-01-26

ApplicantFormedco, Inc.
Decision Date1984-01-26
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROTARY VASCULAR KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Formedco, Inc.. It received FDA 510(k) clearance on 1984-01-26 under 510(k) number K833547. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTARY VASCULAR KNIFE?

ROTARY VASCULAR KNIFE is a medical device that received FDA 510(k) clearance on 1984-01-26. The listed applicant is Formedco, Inc.. The 510(k) number is K833547.

When did ROTARY VASCULAR KNIFE receive FDA 510(k) clearance?

ROTARY VASCULAR KNIFE received FDA 510(k) clearance on 1984-01-26, under 510(k) number K833547.

Who is the listed applicant for ROTARY VASCULAR KNIFE?

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

What is the FDA product code for ROTARY VASCULAR KNIFE?

The FDA product code for ROTARY VASCULAR KNIFE is DWS.

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Related Devices (Code: DWS)

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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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