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FDA 510(k)

SCIMED ANGIOGRAPHIC CATHETERS

K-Number: K992142 · 1999-07-21

ApplicantScimed
Decision Date1999-07-21
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED ANGIOGRAPHIC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Scimed. It received FDA 510(k) clearance on 1999-07-21 under 510(k) number K992142. 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 SCIMED ANGIOGRAPHIC CATHETERS?

SCIMED ANGIOGRAPHIC CATHETERS is a medical device that received FDA 510(k) clearance on 1999-07-21. The listed applicant is Scimed. The 510(k) number is K992142.

When did SCIMED ANGIOGRAPHIC CATHETERS receive FDA 510(k) clearance?

SCIMED ANGIOGRAPHIC CATHETERS received FDA 510(k) clearance on 1999-07-21, under 510(k) number K992142.

Who is the listed applicant for SCIMED ANGIOGRAPHIC CATHETERS?

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

What is the FDA product code for SCIMED ANGIOGRAPHIC CATHETERS?

The FDA product code for SCIMED ANGIOGRAPHIC CATHETERS is DQO.

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Other records listing Scimed 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.

K953909SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETERK931584SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.K922706SCIMED SIDELINERK915347SCIMED VIPER CATHETERK9109877FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVEK904171SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

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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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