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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 Aug 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 314 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 16, 1977
Date Received
Aug 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
510(k) Exempt

Other clearances by Cordis Corp.

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  • K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (May 4, 2012)
  • K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (Jul 9, 2010)
  • K082143 — MICRO GUIDE CATHETER XP (Aug 25, 2008)
  • K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB… (Feb 6, 2008)
  • K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL… (Apr 27, 2006)
  • K050645 — CORDIS AMIIA .014 PTA BALLOON CATHETER (Apr 1, 2005)
  • K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (Dec 17, 2004)
  • K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (Nov 8, 2004)
  • K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY… (Dec 22, 2003)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (Oct 11, 1996)
  • K934391 — V/P AND L/P CATHETER PASSERS (Nov 19, 1993)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (Sep 10, 1993)
  • K932273 — CORDIS TUNNELER (Aug 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (Oct 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (Sep 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (Dec 18, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (Jan 13, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (Sep 18, 1985)
  • K853368 — H-H SHUNT INTRODUCER (Sep 6, 1985)

FDA data resources

Source: FDA 510(k) database entry for K771529. Report a data issue: hello@regdatalab.com.