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510(k) K801552

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR by Edwards Laboratories — Product Code KRB

K801552 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
July 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

Other clearances by Edwards Laboratories

  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (March 17, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A (February 26, 1979)
  • K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS (January 15, 1979)
  • K781535 — AC ADAPTER:MODELS 9525,9526,9527 (September 15, 1978)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K771046 — VENA CAVA UMBRELLA FILTER, MODEL 7321 (June 22, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

Other clearances for product code KRB

  • K171620 — PiCCO Catheter (February 21, 2018)
  • K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (December 7, 2010)
  • K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (September 19, 2007)
  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)
  • K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (March 25, 1994)
  • K915627 — PACEVIEW (March 27, 1992)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)
  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)

FDA data resources