Product code PNQ— Cardiovascular

Permaseal

Classification name: Apical Closure Device
Device class: Class 2
Regulation: 21 CFR 870.4510
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 2016-07-27
Most recent: 2016-07-27

FDA classification definition

“This device is intended for closure of cardiac apical tissue.”
— U.S. Food and Drug Administration, device classification record for product code PNQ under 21 CFR 870.4510, via openFDA

Market context for product code PNQ

FDA has cleared 1 device under product code PNQ, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PNQ

Micro Interventional Devices,Inc.1 clearance

Recent clearances under product code PNQ

DEN150029 — PermasealMicro Interventional Devices,Inc.·2016-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.