510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150029Unknown

Permaseal

Micro Interventional Devices,Inc., Newtown PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN150029 is the FDA 510(k) clearance record for Permaseal, a class II device, cleared for Micro Interventional Devices,Inc. on under FDA product code PNQ (Apical Closure Device). FDA's definition for product code PNQ reads: "This device is intended for closure of cardiac apical tissue". FDA records list one 510(k) clearance for Micro Interventional Devices,Inc. As of , FDA records show no recalls naming DEN150029.

Clearance record

Decision date
Received
(401 days to decision)
Product code
PNQ Apical Closure Device
Regulation
21 CFR 870.4510
Device class
Class II
Review panel
Cardiovascular
Applicant
Micro Interventional Devices,Inc. 5 Caufield Pl., Suite 102, Newtown PA
Third party review
No

Clearances, product code PNQ

Trailing 12 months

FDA records hold no clearances under product code PNQ in the trailing twelve months.

FDA records show no clearances under product code PNQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260