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FDA 510(k)

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

K-Number: K893680 · 1989-08-01

ApplicantCathlab Corp.
Decision Date1989-08-01
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Cathlab Corp.. It received FDA 510(k) clearance on 1989-08-01 under 510(k) number K893680. 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 SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.?

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. is a medical device that received FDA 510(k) clearance on 1989-08-01. The listed applicant is Cathlab Corp.. The 510(k) number is K893680.

When did SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. receive FDA 510(k) clearance?

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. received FDA 510(k) clearance on 1989-08-01, under 510(k) number K893680.

Who is the listed applicant for SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.?

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

What is the FDA product code for SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.?

The FDA product code for SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. is DXE.

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Other records listing Cathlab 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.

K910917CATHLAB SILICONE BILIARY BALLOON CATHETERK910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERK905139CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETERK897051MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATHK8971843F AND 4F IRRIGATION EMBOLECTOMY CATHETERSK893435SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

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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.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK213771Merlin Aspiration SystemMivi Neurovascular, Inc.

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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