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FDA 510(k)

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER

K-Number: K864007 · 1987-01-02

ApplicantUresil Corp.
Decision Date1987-01-02
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1987-01-02 under 510(k) number K864007. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER?

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1987-01-02. The listed applicant is Uresil Corp.. The 510(k) number is K864007.

When did EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER receive FDA 510(k) clearance?

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER received FDA 510(k) clearance on 1987-01-02, under 510(k) number K864007.

Who is the listed applicant for EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER?

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

What is the FDA product code for EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER?

The FDA product code for EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER is DXE.

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Other records listing Uresil Corp. as applicant

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Related Devices (Code: DXE)

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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