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FDA 510(k)

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET

K-Number: K870556 · 1987-03-10

ApplicantVan-Tec, Inc.
Decision Date1987-03-10
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Van-Tec, Inc.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K870556. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET?

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Van-Tec, Inc.. The 510(k) number is K870556.

When did VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET receive FDA 510(k) clearance?

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET received FDA 510(k) clearance on 1987-03-10, under 510(k) number K870556.

Who is the listed applicant for VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET?

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

What is the FDA product code for VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET?

The FDA product code for VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET is KOB.

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Other records listing Van-Tec, 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.

K880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUPK880095BERGER PROSTATE CULTURE CYTOLOGY BRUSHK880098VAN-TEC AUTO BIOPSY NEEDLEK880099VAN-TEC BLADDER EVACUATORK880094VAN-TEC ENDOPYELOTOMY KNIFEK874112VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

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Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.

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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