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FDA 510(k)

BIOSENSORS EMBOLECTOMY CATHETER

K-Number: K973477 · 1998-09-04

ApplicantSunscope Intl., Inc.
Decision Date1998-09-04
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSENSORS EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sunscope Intl., Inc.. It received FDA 510(k) clearance on 1998-09-04 under 510(k) number K973477. 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 BIOSENSORS EMBOLECTOMY CATHETER?

BIOSENSORS EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1998-09-04. The listed applicant is Sunscope Intl., Inc.. The 510(k) number is K973477.

When did BIOSENSORS EMBOLECTOMY CATHETER receive FDA 510(k) clearance?

BIOSENSORS EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1998-09-04, under 510(k) number K973477.

Who is the listed applicant for BIOSENSORS EMBOLECTOMY CATHETER?

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

What is the FDA product code for BIOSENSORS EMBOLECTOMY CATHETER?

The FDA product code for BIOSENSORS EMBOLECTOMY CATHETER is DXE.

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Other records listing Sunscope Intl., Inc. 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.

K002786BIOSENSORS CENTRAL VENOUS CATHETER KITSK983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPK981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXK981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXK911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIESK912172SAFEWEDGE(TM) RELIEF VALVE DEVICE

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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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