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510(k) K862971

MICRA MICROSURGICAL INSTRUMENTS by Cordis Corp. — Product Code GZX

K862971 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "MICRA MICROSURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 25, 1986. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1986
Date Received
August 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Microsurgical
Device Class
Class I
Regulation Number
882.4525
Review Panel
NE
Submission Type

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 (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 GZX

  • K932169 — MICROSURGICAL INSTRUMENTS (July 20, 1993)
  • K926048 — CLARUS ENDOSCOPIC BALL PROBE (April 7, 1993)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K873934 — RANGE OF CROCODILE ACTION INSTRUMENTS (December 17, 1987)
  • K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (December 17, 1987)
  • K853161 — THE VICKERS STANDARD MICROSURGERY SET (November 7, 1985)
  • K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (November 7, 1985)
  • K853180 — VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (October 28, 1985)
  • K853181 — VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (October 28, 1985)

FDA data resources