Pinpoint GT Safety Introducer Needle
FDA 510(k) K142445 · C.R. Bard, Inc.
510(k) numberK142445
Submission
- Device name
- Pinpoint GT Safety Introducer Needle
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- September 2, 2014
- Decision date
- April 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Pinpoint GT Safety Introducer Needle cleared by the FDA?
Pinpoint GT Safety Introducer Needle (K142445) received a 510(k) decision of Substantially Equivalent on April 13, 2015, 223 days after the submission was received.
What is the product code of K142445?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.