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FDA 510(k)

BIO PACK MODEL 200

K-Number: K853126 · 1985-10-11

ApplicantBio Medicus, Inc.
Decision Date1985-10-11
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO PACK MODEL 200 is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medicus, Inc.. It received FDA 510(k) clearance on 1985-10-11 under 510(k) number K853126. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO PACK MODEL 200?

BIO PACK MODEL 200 is a medical device that received FDA 510(k) clearance on 1985-10-11. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K853126.

When did BIO PACK MODEL 200 receive FDA 510(k) clearance?

BIO PACK MODEL 200 received FDA 510(k) clearance on 1985-10-11, under 510(k) number K853126.

Who is the listed applicant for BIO PACK MODEL 200?

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

What is the FDA product code for BIO PACK MODEL 200?

The FDA product code for BIO PACK MODEL 200 is DWA.

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Other records listing Bio Medicus, Inc. as applicant

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K920761URINE CULTUR STABILIZATION TRANSPORT TUBEK903410BIO-MEDICUS CANNULA INTRODUCERK901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B CK894980BIO-CAL 370 HEATER/COOLERK884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET

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Related Devices (Code: DWA)

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.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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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