Starclose Introducer Set Model- 1002

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060902

Identifiers

510(k) Number: K060902 FDA 510(k)
FDA Product Code: DYB FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1340 FDA 510(k)
Regulation Number: 870.1340 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Introducing the STARCLOSE INTRODUCER SET MODEL-1002, a high-quality introducer set designed for safe and effective catheterization. This device features a durable design, easy-to-use interface, and precise control, making it an ideal choice for healthcare professionals seeking to improve their diagnostic and interventional procedures.

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	K060902	Class II	Active

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Manufacturer

Manufacturer: Abbott Vascular Inc.
FDA Applicant: Abbott Vascular, Inc.

Sources (1)

FDA 510(k) K060902 24 fields · synced Jul 1, 2026