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FDA 510(k)

RESPIRATORY CIRCUIT ADAPTOR

K-Number: K823287 · 1982-12-09

ApplicantThoratec Laboratories Corp.
Decision Date1982-12-09
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY CIRCUIT ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 1982-12-09 under 510(k) number K823287. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY CIRCUIT ADAPTOR?

RESPIRATORY CIRCUIT ADAPTOR is a medical device that received FDA 510(k) clearance on 1982-12-09. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K823287.

When did RESPIRATORY CIRCUIT ADAPTOR receive FDA 510(k) clearance?

RESPIRATORY CIRCUIT ADAPTOR received FDA 510(k) clearance on 1982-12-09, under 510(k) number K823287.

Who is the listed applicant for RESPIRATORY CIRCUIT ADAPTOR?

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

What is the FDA product code for RESPIRATORY CIRCUIT ADAPTOR?

The FDA product code for RESPIRATORY CIRCUIT ADAPTOR is BZO.

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Other records listing Thoratec Laboratories Corp. 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.

K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAMEK001926VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIESK851495THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAYK833714RESPIRATORY ASSESSMENT SYSTEMK833265RESPIRATORY FLOW MODULEK831557INTRAOPERATIVE AUTOTRANSFUSION SYS

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Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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