Home / 510(k) Clearances / K771529

510(k) K771529

PERITONEAL INTRODUCER & SHEATH by Cordis Corp. — Product Code GYK

K771529 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "PERITONEAL INTRODUCER & SHEATH". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
August 8, 1977
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 Cordis Corp.

  • K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EX (March 12, 2014)
  • K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (May 4, 2012)
  • K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (July 9, 2010)
  • K082143 — MICRO GUIDE CATHETER XP (August 25, 2008)
  • K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB (February 6, 2008)
  • K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,B (April 27, 2006)
  • K050645 — CORDIS AMIIA .014 PTA BALLOON CATHETER (April 1, 2005)
  • K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (December 17, 2004)
  • K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (November 8, 2004)
  • K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTE (December 22, 2003)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (October 11, 1996)
  • K934391 — V/P AND L/P CATHETER PASSERS (November 19, 1993)
  • 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)

FDA data resources