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FDA 510(k)

VASOVIEW BALLOON DISSECTION SYSTEM

K-Number: K964171 · 1997-02-14

ApplicantOrigin Medsystems, Inc.
Decision Date1997-02-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VASOVIEW BALLOON DISSECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K964171. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASOVIEW BALLOON DISSECTION SYSTEM?

VASOVIEW BALLOON DISSECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K964171.

When did VASOVIEW BALLOON DISSECTION SYSTEM receive FDA 510(k) clearance?

VASOVIEW BALLOON DISSECTION SYSTEM received FDA 510(k) clearance on 1997-02-14, under 510(k) number K964171.

Who is the listed applicant for VASOVIEW BALLOON DISSECTION SYSTEM?

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

What is the FDA product code for VASOVIEW BALLOON DISSECTION SYSTEM?

The FDA product code for VASOVIEW BALLOON DISSECTION SYSTEM is GCJ.

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Other records listing Origin Medsystems, Inc. as applicant

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K992353BLUNT TIP TROCAR PORTK981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEMK972685ORIGIN LIGATOR DEVICEK970611ORIGIN CARDIAC STABLIZER OCCLUDERK965121CANNULAK962104AIRLIFT BALLOON RETRACTON SYSTEM

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Related Devices (Code: GCJ)

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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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