Substantially Equivalent 510(k) Device Information
Applicant: Terumo Medical Corp., Elkton, MD
510(k) number: BK970011
Product: Terumo Phlebotomy Needle Cap Holder
Date: 05/19/97
Summary of Safety and Effectiveness
Proprietary Name:
Terumo Phlebotomy Needle cap Holder
Common Name:
Phlebotomy Needle Cap Holder
Description:
The Phlebotomy Needle Cap Holder is a single-piece molded device made of a single thermoplastic.
Intended Use:
The Terumo Phlebotomy Needle Cap Holder is designed for multiple use. The device is intended to aid the phlebotomist in covering the donor phlebotomy needle subsequent to the removal of the needle from the donor's arm.
Substantially Equivalent Devices:
- Cutter Phlebotomist Protection Device
- Fenwal Needle/Tube Sampling Protector Device
The Terumo device and the above devices are all intended to assist in
Recovering the used phlebotomy needle. The Cutter and Fenwal devices
also permit collection of blood samples into evacuated blood collection
tubes. In all three devices the needles are manually placed into a cap or
Covering assembly.
Although the physical characteristics differ among the devices, the
devices are substantially equivalent in their intended indication for
recovering the used needle.
All three devices are made of a thermoplastic material.
Performance testing in the blood bank setting demonstrated the Terumo
device performed as well as or better than the Baxter device.
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