Home / 510(k) Clearances / K981035

510(k) K981035

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES by Sims Portex, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
March 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sims Portex, Inc.

  • K012277 — PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE (February 11, 2002)
  • K012068 — WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEON (August 3, 2001)
  • K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PR (July 12, 2001)
  • K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (February 5, 2001)
  • K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (December 14, 2000)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)
  • K001318 — CPAP SYSTEM, MODEL 102001 (July 20, 2000)
  • K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (April 28, 2000)
  • K000628 — WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET- (March 13, 2000)
  • K994275 — SIMS PORTEX ANESTHESIA CATHETER (February 22, 2000)

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