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510(k) K790938

SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO by Shiley, Inc. — Product Code DWP

K790938 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO". The FDA issued a decision of Substantially Equivalent on June 13, 1979. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Shiley, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1979
Date Received
May 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

Other clearances by Shiley, Inc.

  • K920594 — SHILEY PERFUSION TUBING SETS (March 18, 1993)
  • K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (November 27, 1991)
  • K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (August 9, 1991)
  • K910923 — BCD ADVANCED (April 9, 1991)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code DWP

  • K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (April 20, 2023)
  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)

FDA data resources