510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082191Substantially Equivalent

Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080

Cardiomems, Inc., Atlanta GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082191 is the FDA 510(k) clearance record for CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080, a class II device, cleared for Cardiomems, Inc. on under FDA product code NQH (Sensor, Pressure, Aneurysm, Implantable). FDA's definition for product code NQH reads: "This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure". FDA records list 5 510(k) clearances for Cardiomems, Inc., from to . As of , FDA records show no recalls naming K082191.

Clearance record

Decision date
Received
(15 days to decision)
Product code
NQH Sensor, Pressure, Aneurysm, Implantable
Regulation
21 CFR 870.2855
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiomems, Inc. 387 Technology Cir. NW, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQH

Trailing 12 months

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

FDA records show no clearances under product code NQH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQH, 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