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510(k) K912172

SAFEWEDGE(TM) RELIEF VALVE DEVICE by Sunscope Intl., Inc. — Product Code KRB

K912172 is an FDA 510(k) premarket notification submitted by Sunscope Intl., Inc. for the device "SAFEWEDGE(TM) RELIEF VALVE DEVICE". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Sunscope Intl., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
May 16, 1991
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 Sunscope Intl., Inc.

  • K002786 — BIOSENSORS CENTRAL VENOUS CATHETER KITS (November 17, 2000)
  • K983372 — BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP (February 5, 1999)
  • K973477 — BIOSENSORS EMBOLECTOMY CATHETER (September 4, 1998)
  • K981747 — BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (August 20, 1998)
  • K981745 — BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (July 17, 1998)
  • K911710 — HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (October 23, 1991)

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)
  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K900317 — PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (June 22, 1990)

FDA data resources