Home / 510(k) Clearances / K812761

510(k) K812761

FLOW-DIRECTED BALLOON THERMODILUTION by Nova Medical Specialties — Product Code KRG

K812761 is an FDA 510(k) premarket notification submitted by Nova Medical Specialties for the device "FLOW-DIRECTED BALLOON THERMODILUTION". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Nova Medical Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
October 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type

Other clearances by Nova Medical Specialties

  • K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. (October 15, 1987)
  • K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (May 2, 1986)
  • K853625 — NOVA ARTERIAL EMBOLECTOMY CATHETER (January 15, 1986)
  • K840009 — NOVA 12 CARDIAC OUTPUT COMPUTER (August 22, 1984)
  • K841640 — NOVA BALLOON THERMODILUTION INFUSION (August 12, 1984)
  • K841639 — NOVA BALLOON THERMODILUTION CATH. (August 12, 1984)
  • K834037 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K834036 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K832287 — NOVA BALLOON THERMODILUTION INFUSION (October 19, 1983)
  • K822806 — BALLOON WEDGE PRESSURE, ANGIOGRAPHIC (November 1, 1982)

Other clearances for product code KRG

  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K884522 — MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (August 25, 1989)
  • K880738 — MODEL 2331T PATIENT PROGRAMMER (November 17, 1988)
  • K882429 — MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (July 22, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K871986 — MODEL 5600B PROGRAMMER, PACEMAKER (June 24, 1987)
  • K863046 — ULTRA SOFTWARE MODULE: MODEL 2016 (December 5, 1986)
  • K863045 — PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (September 29, 1986)
  • K860584 — SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (June 6, 1986)
  • K860546 — DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (April 23, 1986)

FDA data resources