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510(k) K851048

CHEST CATHETERS/THORACIC CATHETERS by Medovations, Inc. — Product Code GBS

K851048 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "CHEST CATHETERS/THORACIC CATHETERS". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
March 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Medovations, Inc.

  • K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING (March 10, 2015)
  • K002363 — MEDOVATIONS ESOPHAGEAL DILATOR (November 1, 2000)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)

FDA data resources