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FDA 510(k)

DUAL BALLOON EMBOLECTOMY CATHETER

K-Number: K914880 · 1992-03-16

ApplicantIdeal Medical, Inc.
Decision Date1992-03-16
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL BALLOON EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ideal Medical, Inc.. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K914880. 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 DUAL BALLOON EMBOLECTOMY CATHETER?

DUAL BALLOON EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is Ideal Medical, Inc.. The 510(k) number is K914880.

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

DUAL BALLOON EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1992-03-16, under 510(k) number K914880.

Who is the listed applicant for DUAL BALLOON EMBOLECTOMY CATHETER?

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

What is the FDA product code for DUAL BALLOON EMBOLECTOMY CATHETER?

The FDA product code for DUAL BALLOON EMBOLECTOMY CATHETER is DXE.

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Other records listing Ideal Medical, 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.

K944067PEANUT WAND, MODIFICATIONK931115HATCHER STONE-EMBOLIS EXTRACTORK926335IDEAS PEANUT WANDK922161GRICE SOFT TISSUE BIOPSY KITK921922GRICE LAPAROSCOPIC SUTURING NEEDLEK915175REDDICK RETRACTOR

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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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