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FDA 510(k)

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000

K-Number: K901253 · 1990-09-05

ApplicantBio Medicus, Inc.
Decision Date1990-09-05
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 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 1990-09-05 under 510(k) number K901253. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000?

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 is a medical device that received FDA 510(k) clearance on 1990-09-05. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K901253.

When did (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 receive FDA 510(k) clearance?

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 received FDA 510(k) clearance on 1990-09-05, under 510(k) number K901253.

Who is the listed applicant for (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000?

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 (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000?

The FDA product code for (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 is DTZ.

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Related Devices (Code: DTZ)

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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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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