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Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241243

by Centerline Biomedical, Inc.

Identifiers

510(k) Number
K241243 FDA 510(k)
FDA Product Code
DQK FDA 510(k)
Models / Variants
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) FDA 510(k)
Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +… by Centerline Biomedical, Inc. — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Centerline Biomedical, Inc.

Sources (1)

  • FDA 510(k) K241243 24 fields · synced Jun 18, 2026