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FDA 510(k)

URESIL OCCLUSION BALLOON CATHETER

K-Number: K863559 · 1986-10-10

ApplicantUresil Corp.
Decision Date1986-10-10
Product CodeDQT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

URESIL OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1986-10-10 under 510(k) number K863559. The device is classified under product code DQT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL OCCLUSION BALLOON CATHETER?

URESIL OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1986-10-10. The listed applicant is Uresil Corp.. The 510(k) number is K863559.

When did URESIL OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

URESIL OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 1986-10-10, under 510(k) number K863559.

Who is the listed applicant for URESIL OCCLUSION BALLOON CATHETER?

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

What is the FDA product code for URESIL OCCLUSION BALLOON CATHETER?

The FDA product code for URESIL OCCLUSION BALLOON CATHETER is DQT.

Related Clinical Trials

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Other records listing Uresil 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.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

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Related Devices (Code: DQT)

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.

K983927GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORTArterial Vascular Engineering, Inc.K945963THE OMNIGUIDE GUIDING CATHETER WITH BALLOONMicro Interventional Systems, Inc.K910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERCathlab Corp.K910339AVD INTIMAX OCCLUSION CATHETERApplied Vascular Devices, Inc.K880860CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015Dlp, Inc.K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, 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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