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FDA 510(k)

SURE-FLEX ANASTOMOTIC BALLOON DILATOR

K-Number: K901433 · 1990-06-21

ApplicantTelemed Systems, Inc.
Decision Date1990-06-21
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURE-FLEX ANASTOMOTIC BALLOON DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 1990-06-21 under 510(k) number K901433. 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 SURE-FLEX ANASTOMOTIC BALLOON DILATOR?

SURE-FLEX ANASTOMOTIC BALLOON DILATOR is a medical device that received FDA 510(k) clearance on 1990-06-21. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K901433.

When did SURE-FLEX ANASTOMOTIC BALLOON DILATOR receive FDA 510(k) clearance?

SURE-FLEX ANASTOMOTIC BALLOON DILATOR received FDA 510(k) clearance on 1990-06-21, under 510(k) number K901433.

Who is the listed applicant for SURE-FLEX ANASTOMOTIC BALLOON DILATOR?

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

What is the FDA product code for SURE-FLEX ANASTOMOTIC BALLOON DILATOR?

The FDA product code for SURE-FLEX ANASTOMOTIC BALLOON DILATOR is FGE.

Related Clinical Trials

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Other records listing Telemed Systems, 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.

K020379PPD BALLOON DILATATION CATHETERK013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK010412FLEXIBLE ENDOSCOPIC SCISSORSK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR

View all 22 devices →

Related Devices (Code: FGE)

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.

K254179Drainage CatheterCanyon Medical, Inc.K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019Hangzhou AGS MedTech Co., Ltd.K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH

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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