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510(k) K943968

TUNNELER by Denver Biomedicals, Inc. — Product Code MDM

K943968 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "TUNNELER". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
August 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Denver Biomedicals, Inc.

  • K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (June 13, 2005)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS (March 20, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU (January 2, 2001)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K842139 — THE DENVER PLEURAL-PERITONEAL SHUNT (August 27, 1984)
  • K822686 — DENVER PERITONEO-VENOUS SHUNT (DP-VS) (September 21, 1982)
  • K811577 — CROUCH CORNEAL PROTECTOR (August 7, 1981)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (July 1, 1981)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K945430 — DERMAVBLADE(TM) (November 28, 1994)

FDA data resources