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510(k) K202325

EasyPoint Blood Collection Plus by Retractable Technologies, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2021
Date Received
August 17, 2020
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 Retractable Technologies, Inc.

  • K133635 — EASYPOINT NEEDLE (June 17, 2014)
  • K122355 — VANISHPOINT BLOOD COLLECTION SET (August 23, 2013)
  • K112512 — VANISHPOINT BLOOD COLLECTION SET (October 20, 2011)
  • K101708 — PATIENT SAFE LUER CAP (February 24, 2011)
  • K081420 — VANISHPOINT I.V. CATHETER (November 7, 2008)
  • K072654 — PATIENT SAFE SYRINGE (December 14, 2007)
  • K051355 — VANISHPOINT I.V. CATHETER (September 23, 2005)
  • K980069 — VANISHPOINT SYRINGE (February 12, 1998)
  • K973301 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE (November 7, 1997)
  • K971763 — BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (August 26, 1997)

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  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
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