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510(k) K841468

PMA ANGIOGRAPHY TRAY by Professional Medical Services — Product Code DWS

K841468 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PMA ANGIOGRAPHY TRAY". The FDA issued a decision of Substantially Equivalent on June 5, 1984. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1984
Date Received
April 9, 1984
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 Professional Medical Services

  • K913094 — DISPOSABLE SLIDE VALVE MANIFOLD (January 27, 1992)
  • K910378 — PRESSURE MONITORING EXTENSION LINE (April 22, 1991)
  • K904508 — CONDOR ANALOG INFLATION SYRINGE (April 2, 1991)
  • K904954 — CONDOR DIGITAL INFLATION SYRINGE (January 16, 1991)
  • K902606 — RADIOPAQUE RULER (September 27, 1990)
  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
  • K890471 — PMS ANGIO DRAPE (February 27, 1989)
  • K884497 — CONTROL SYRINGE (December 12, 1988)
  • K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
  • K864555 — 3 RING ATTACHMENT (December 1, 1986)

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