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FDA 510(k)

ATRAUMATIC TIP ANGIOGRAPHIC CATHETER

K-Number: K915136 · 1992-01-27

ApplicantExonix Research Corp.
Decision Date1992-01-27
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRAUMATIC TIP ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Exonix Research Corp.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K915136. 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 ATRAUMATIC TIP ANGIOGRAPHIC CATHETER?

ATRAUMATIC TIP ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Exonix Research Corp.. The 510(k) number is K915136.

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

ATRAUMATIC TIP ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915136.

Who is the listed applicant for ATRAUMATIC TIP ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for ATRAUMATIC TIP ANGIOGRAPHIC CATHETER?

The FDA product code for ATRAUMATIC TIP ANGIOGRAPHIC CATHETER is DQO.

Related Clinical Trials

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.

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Other records listing Exonix Research 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.

K923681EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI

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

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