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FDA 510(k)

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER

K-Number: K901603 · 1990-05-04

ApplicantBivona Medical Technologies
Decision Date1990-05-04
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1990-05-04 under 510(k) number K901603. 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 MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER?

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Bivona Medical Technologies. The 510(k) number is K901603.

When did MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER receive FDA 510(k) clearance?

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER received FDA 510(k) clearance on 1990-05-04, under 510(k) number K901603.

Who is the listed applicant for MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER?

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

What is the FDA product code for MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER?

The FDA product code for MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER is KOB.

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Other records listing Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

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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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