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510(k) K884915

DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER by Dantec Electronics, Inc. — Product Code FAP

K884915 is an FDA 510(k) premarket notification submitted by Dantec Electronics, Inc. for the device "DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER". The FDA issued a decision of Substantially Equivalent on October 4, 1989. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Dantec Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Dantec Electronics, Inc.

  • K895460 — CONCENTRIC ELECTRODE TYPE #13R01, 13R02 (June 18, 1990)
  • K894911 — SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 (May 14, 1990)
  • K881915 — DANTEC MAGNETIC STIMULATOR (October 17, 1988)
  • K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (April 14, 1988)
  • K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (April 14, 1988)
  • K874735 — DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE (January 22, 1988)
  • K870567 — EVOPORT 300 (October 6, 1987)
  • K872106 — DANTEC COUNTERPOINT (September 10, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)

Other clearances for product code FAP

  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (February 19, 1998)
  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)

FDA data resources