Tapered Tip The Guider Coronary Guiding Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K903217

Identifiers

510(k) Number: K903217 FDA 510(k)
FDA Product Code: DQY FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1250 FDA 510(k)
Regulation Number: 870.1250 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER is a high-quality medical device used in cardiac interventions. This device features a tapered tip design, providing precise control and accuracy during coronary procedures. The device's ergonomic handle and intuitive design make it easy to maneuver, allowing for comfortable use by healthcare professionals.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K903217	Class II	Active

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Manufacturer

Manufacturer: Intec Medical, Inc.

Sources (1)

FDA 510(k) K903217 24 fields · synced Jul 23, 2026