510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211830Substantially Equivalent

LifeSPARC System

Cardiacassist, Inc., Pittsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211830 is the FDA 510(k) clearance record for LifeSPARC System, a class II device, cleared for Cardiacassist, Inc. on under FDA product code QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use). FDA's definition for product code QNR reads: "A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with...". FDA records list 21 510(k) clearances for Cardiacassist, Inc., from to . As of , FDA records show no recalls naming K211830.

Clearance record

Decision date
Received
(519 days to decision)
Product code
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiacassist, Inc. 620 Alpha Dr. Suite 2, Pittsburg PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNR

Trailing 12 months

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

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