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510(k) K841521

SCANLAN ENDARSECTOR by Scanlan Intl., Inc. — Product Code DWX

K841521 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN ENDARSECTOR". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
April 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Scanlan Intl., Inc.

  • K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (April 26, 1996)
  • K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER (December 5, 1994)
  • K911184 — SCANLAN/TAHERI VALVULOTOME (February 18, 1992)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K851825 — SCANLAN TUNNELER, SHEATH & TIP (July 12, 1985)
  • K841513 — SCANLAN ATRAUM INSTRUMENT JAW COVER (July 6, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)

Other clearances for product code DWX

  • K121415 — MOLLRING MULTITASC (September 5, 2012)
  • K032105 — ENDOHELIX ENDARTERECTOMY DEVICE (October 30, 2003)
  • K020925 — CARBODISSECTING ENDOSCOPE (April 29, 2003)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)
  • K950813 — MOLLRING CUTTER (July 25, 1995)
  • K933498 — EXTERNAL VEIN STRIPPER (March 23, 1994)
  • K913803 — INTRALUMINAL ARTERY STRIPPER (April 24, 1992)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 17, 1990)
  • K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP (January 2, 1990)

FDA data resources