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FDA 510(k)

ANGIOGRAPHIC SOFT TIP CATHETER

K-Number: K914199 · 1991-12-18

ApplicantE-Z-Em, Inc.
Decision Date1991-12-18
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOGRAPHIC SOFT TIP CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914199. 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 ANGIOGRAPHIC SOFT TIP CATHETER?

ANGIOGRAPHIC SOFT TIP CATHETER is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K914199.

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

ANGIOGRAPHIC SOFT TIP CATHETER received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914199.

Who is the listed applicant for ANGIOGRAPHIC SOFT TIP CATHETER?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing E-Z-Em, Inc. as applicant

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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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