BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK

Stents, Drains And Dilators For The Biliary Ducts

BIOTEQUE CORP.

The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteq Pigtail Drainage Catheter Set (one Step Type) With Or Without Safety String Lock.

Pre-market Notification Details

• Device ID: K033862
• 510k Number: K033862
• Device Name: BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
• Classification: Stents, Drains And Dilators For The Biliary Ducts
• Applicant: BIOTEQUE CORP. 8F-3, NO. 136, SEC. 3, JEN-AI ROAD Taipei, TW
• Contact: William Lee
• Correspondent: William Lee; BIOTEQUE CORP. 8F-3, NO. 136, SEC. 3, JEN-AI ROAD Taipei, TW
• Product Code: FGE
• CFR Regulation Number: 876.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-12
• Decision Date: 2005-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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