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FDA 510(k)

URE SIL EMBOLECTOMY/THROMBECTOMY CATH

K-Number: K812640 · 1981-10-02

ApplicantUresil Corp.
Decision Date1981-10-02
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

URE SIL EMBOLECTOMY/THROMBECTOMY CATH is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812640. 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 URE SIL EMBOLECTOMY/THROMBECTOMY CATH?

URE SIL EMBOLECTOMY/THROMBECTOMY CATH is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Uresil Corp.. The 510(k) number is K812640.

When did URE SIL EMBOLECTOMY/THROMBECTOMY CATH receive FDA 510(k) clearance?

URE SIL EMBOLECTOMY/THROMBECTOMY CATH received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812640.

Who is the listed applicant for URE SIL EMBOLECTOMY/THROMBECTOMY CATH?

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 URE SIL EMBOLECTOMY/THROMBECTOMY CATH?

The FDA product code for URE SIL EMBOLECTOMY/THROMBECTOMY CATH is DXE.

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Other records listing Uresil Corp. as applicant

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.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

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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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