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FDA 510(k)

SINGLE AND DUAL TOURNIQUET CUFF

K-Number: K860463 · 1986-02-25

ApplicantAspen Laboratories, Inc.
Decision Date1986-02-25
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINGLE AND DUAL TOURNIQUET CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-25 under 510(k) number K860463. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE AND DUAL TOURNIQUET CUFF?

SINGLE AND DUAL TOURNIQUET CUFF is a medical device that received FDA 510(k) clearance on 1986-02-25. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K860463.

When did SINGLE AND DUAL TOURNIQUET CUFF receive FDA 510(k) clearance?

SINGLE AND DUAL TOURNIQUET CUFF received FDA 510(k) clearance on 1986-02-25, under 510(k) number K860463.

Who is the listed applicant for SINGLE AND DUAL TOURNIQUET CUFF?

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

What is the FDA product code for SINGLE AND DUAL TOURNIQUET CUFF?

The FDA product code for SINGLE AND DUAL TOURNIQUET CUFF is KCY.

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Other records listing Aspen Laboratories, Inc. as applicant

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.

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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