the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
FDA 510(k) K162322 · Access Scientific, LLC
510(k) numberK162322
Submission
- Device name
- the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
- Applicant
- Access Scientific, LLC
San Diego, CA, US - Received
- August 19, 2016
- Decision date
- November 17, 2016
- 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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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…DYB · Traditional | 07/25/2019SE |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with…DQY · Traditional | 09/26/2018SE |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable SheathDYB · Special | 09/18/2018SE |
| K131148 | The CVC Wand Safety Introducer with Valved Peelable SheathDYB · Traditional | 09/04/2013SE |
| K131300 | The Powerwand Safety Introducer with an Extended Dwell CatheterDYB · Special | 06/07/2013SE |
| K121748 | The Powerwand Safety Introducer with and Extended DwellDYB · Special | 07/27/2012SE |
| K111417 | The Powerwand (R) Safety Introducer with an Extended Dwell CatheterDYB · Special | 07/15/2011SE |
| K111138 | The Picc Wand (R) Peelable Safety IntroducerDYB · Special | 06/22/2011SE |
| K101422 | The Power Wand Safety Introducer with an Extended Dwell CatheterDYB · Traditional | 03/22/2011SE |
| K101150 | Picc Wand Peelable Safety IntroducerDYB · Special | 08/13/2010SE |
Questions and answers
When was the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model cleared by the FDA?
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (K162322) received a 510(k) decision of Substantially Equivalent on November 17, 2016, 90 days after the submission was received.
What is the product code of K162322?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.