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FDA 510(k)

TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER

K-Number: K903217 · 1990-10-19

ApplicantIntec Medical, Inc.
Decision Date1990-10-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K903217. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER?

TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Intec Medical, Inc.. The 510(k) number is K903217.

When did TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER receive FDA 510(k) clearance?

TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER received FDA 510(k) clearance on 1990-10-19, under 510(k) number K903217.

Who is the listed applicant for TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER?

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

What is the FDA product code for TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER?

The FDA product code for TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER is DQY.

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Other records listing Intec Medical, Inc. 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.

K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETERK903216THE GUIDER CORONARY GUIDING CATHETERK900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERK903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYK903906PERCUTANEOUS CATHETER INTRODUCER KITK900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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