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FDA 510(k)

OASIS THROMBECTOMY CATHETER SYSTEM

K-Number: K982363 · 1999-02-23

ApplicantBoston Scientific Corp
Decision Date1999-02-23
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OASIS THROMBECTOMY CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1999-02-23 under 510(k) number K982363. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OASIS THROMBECTOMY CATHETER SYSTEM?

OASIS THROMBECTOMY CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-23. The listed applicant is Boston Scientific Corp. The 510(k) number is K982363.

When did OASIS THROMBECTOMY CATHETER SYSTEM receive FDA 510(k) clearance?

OASIS THROMBECTOMY CATHETER SYSTEM received FDA 510(k) clearance on 1999-02-23, under 510(k) number K982363.

Who is the listed applicant for OASIS THROMBECTOMY CATHETER SYSTEM?

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

What is the FDA product code for OASIS THROMBECTOMY CATHETER SYSTEM?

The FDA product code for OASIS THROMBECTOMY CATHETER SYSTEM is MCW.

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Related Devices (Code: MCW)

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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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