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FDA 510(k)

PORGES 2-WAY BALLOON EXTRACTION CATHETER

K-Number: K896504 · 1990-01-26

ApplicantPorges Corp.
Decision Date1990-01-26
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORGES 2-WAY BALLOON EXTRACTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Porges Corp.. It received FDA 510(k) clearance on 1990-01-26 under 510(k) number K896504. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORGES 2-WAY BALLOON EXTRACTION CATHETER?

PORGES 2-WAY BALLOON EXTRACTION CATHETER is a medical device that received FDA 510(k) clearance on 1990-01-26. The listed applicant is Porges Corp.. The 510(k) number is K896504.

When did PORGES 2-WAY BALLOON EXTRACTION CATHETER receive FDA 510(k) clearance?

PORGES 2-WAY BALLOON EXTRACTION CATHETER received FDA 510(k) clearance on 1990-01-26, under 510(k) number K896504.

Who is the listed applicant for PORGES 2-WAY BALLOON EXTRACTION CATHETER?

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

What is the FDA product code for PORGES 2-WAY BALLOON EXTRACTION CATHETER?

The FDA product code for PORGES 2-WAY BALLOON EXTRACTION CATHETER is FGE.

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Other records listing Porges 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.

K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEK900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSK896505PORGES UNIVERSAL HANDLESK896503PORGES ERCP CATHETERSK896425PORGES CYTOLOGY BRUSHESK896507PORGES DIATHERMY SNARE

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Related Devices (Code: FGE)

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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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