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510(k) K925541

STOCKERT 1/4 BUBBLE SENSOR by Sorin Biomedica, Fiat, USA, Inc. — Product Code KRL

K925541 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "STOCKERT 1/4 BUBBLE SENSOR". The FDA issued a decision of Substantially Equivalent on February 2, 1993. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1993
Date Received
November 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

Other clearances by Sorin Biomedica, Fiat, USA, Inc.

  • K931444 — PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (May 27, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925369 — BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS (March 26, 1993)
  • K925615 — SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (March 26, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K922933 — SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (November 30, 1992)
  • K854963 — S80 IMPLANTABLE CARDIAC PACING LEAD (June 24, 1986)
  • K852641 — ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER (January 14, 1986)
  • K851365 — SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM (December 3, 1985)
  • K841947 — ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (June 25, 1984)

Other clearances for product code KRL

  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K090698 — CAPIOX BUBBLE TRAP WITH X-COATING (June 8, 2009)
  • K071231 — EDAC QUANTIFIER (May 17, 2007)
  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM (October 29, 1996)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K911632 — CAPIOX(R) BUBBLE TRAP (July 9, 1991)
  • K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (February 3, 1987)

FDA data resources