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510(k) K875322

MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER by Schneider-Shilley (Usa) — Product Code KRK

K875322 is an FDA 510(k) premarket notification submitted by Schneider-Shilley (Usa) for the device "MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on March 28, 1988. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140. Schneider-Shilley (Usa) has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1988
Date Received
December 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Blood-Pressure, Venous
Device Class
Class II
Regulation Number
870.1140
Review Panel
CV
Submission Type

Other clearances by Schneider-Shilley (Usa)

  • K882826 — SOFTRAC-PTA PERIPHERAL DILATATION CATHETER (January 24, 1989)
  • K875175 — MODIFIED PERIPHERAL DILATATION CATHETERS (July 28, 1988)
  • K881197 — SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER (May 16, 1988)
  • K875323 — MODIFIED SCHNEIDER-SHILEY WIRE TORQUER (March 28, 1988)
  • K875324 — MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES (March 25, 1988)
  • K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (March 25, 1988)
  • K875325 — MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK (February 18, 1988)
  • K875326 — MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER (February 18, 1988)

Other clearances for product code KRK

  • K950607 — UST-5268P-5 TRANSDUCER (September 15, 1995)
  • K904674 — CENTRAL VENOUS PRESSURE MANOMETER (December 27, 1990)
  • K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (January 5, 1989)
  • K861605 — SCHNEIDER-SHILEY PRESSURE MANOMETER (May 28, 1986)
  • K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
  • K813498 — MEDIFIX (January 7, 1982)
  • K813195 — MEDIFIX GRADUATED SCALE (December 29, 1981)
  • K790668 — VENOUS PRESSURE MONITOR, MF 35 LF (May 23, 1979)

FDA data resources