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510(k) K851825

SCANLAN TUNNELER, SHEATH & TIP by Scanlan Intl., Inc. — Product Code DWS

K851825 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN TUNNELER, SHEATH & TIP". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1985
Date Received
April 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
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)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K841521 — SCANLAN ENDARSECTOR (August 3, 1984)
  • K841513 — SCANLAN ATRAUM INSTRUMENT JAW COVER (July 6, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources