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FDA 510(k)

BIOTEQ ANGIOGRAPHIC CATHETER

K-Number: K102633 · 2011-09-09

ApplicantBioteque Corp.
Decision Date2011-09-09
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTEQ ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K102633. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQ ANGIOGRAPHIC CATHETER?

BIOTEQ ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Bioteque Corp.. The 510(k) number is K102633.

When did BIOTEQ ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

BIOTEQ ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 2011-09-09, under 510(k) number K102633.

Who is the listed applicant for BIOTEQ ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for BIOTEQ ANGIOGRAPHIC CATHETER?

The FDA product code for BIOTEQ ANGIOGRAPHIC CATHETER is DQO.

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Other records listing Bioteque 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.

K150932Sheath IntroducerK033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCKK033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETK032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEXK013634BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACKK012526BIOTEQUE SCALP VEIN SET

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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