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510(k) K934391

V/P AND L/P CATHETER PASSERS by Radionics, Inc. — Product Code GYK

K934391 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "V/P AND L/P CATHETER PASSERS". The FDA issued a decision of Substantially Equivalent on November 19, 1993. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Radionics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1993
Date Received
September 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
Review Panel
NE
Submission Type

Other clearances by Radionics, Inc.

  • K030697 — RADIONICS SINGLE USE GROUND PAD (DGP-HP) (April 4, 2003)
  • K002773 — NEUROMAP WITH NEURO 100 (October 23, 2000)
  • K001741 — RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (October 23, 2000)
  • K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 4, 2000)
  • K001950 — OPTICAL TRACKING SYSTEM (OTS) (July 26, 2000)
  • K001700 — XPLAN 2.1 (June 28, 2000)
  • K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (May 17, 2000)
  • K000057 — RADIONICS LUMBOPERITONEAL SHUNT (March 20, 2000)
  • K993594 — CONFORMAX MMLC VR1 (December 15, 1999)
  • K991399 — RADIONICS MICROELECTRODE KIT (September 21, 1999)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (October 11, 1996)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K932273 — CORDIS TUNNELER (August 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (October 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (September 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (September 18, 1985)
  • K853368 — H-H SHUNT INTRODUCER (September 6, 1985)
  • K841553 — H-H SHUNT PASSERS (May 14, 1984)

FDA data resources