FDA 510(k)

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING

K-Number: K981344 · 1998-09-10

Decision Date1998-09-10

Product CodeLJE

DecisionSubstantially Equivalent

Device Summary

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1998-09-10 under 510(k) number K981344. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING?

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING is a medical device that received FDA 510(k) clearance on 1998-09-10. The listed applicant is Uresil Corp.. The 510(k) number is K981344.

When did URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING receive FDA 510(k) clearance?

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING received FDA 510(k) clearance on 1998-09-10, under 510(k) number K981344.

Who is the listed applicant for URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING?

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 PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING?

The FDA product code for URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING is LJE.

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Other records listing Uresil Corp. as applicant

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE K980278URESIL VASCU-FLO INFUSION CATHETER K980282URESIL DILATOR WITH RADIOPAQUE MARKER K980889URESIL NEPHRO-URETERAL STENT K972582URESIL GUIDEWIRE K972583URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S

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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.