The Power Wand Safety Introducer with an Extended Dwell Catheter
FDA 510(k) K101422 · Access Scientific, Inc.
510(k) numberK101422
Submission
- Device name
- The Power Wand Safety Introducer with an Extended Dwell Catheter
- Applicant
- Access Scientific, Inc.
San Diego, CA, US - Received
- May 20, 2010
- Decision date
- March 22, 2011
- 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 |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelDYB · Traditional | 11/17/2016SE |
| 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 |
| K101150 | Picc Wand Peelable Safety IntroducerDYB · Special | 08/13/2010SE |
Questions and answers
When was The Power Wand Safety Introducer with an Extended Dwell Catheter cleared by the FDA?
The Power Wand Safety Introducer with an Extended Dwell Catheter (K101422) received a 510(k) decision of Substantially Equivalent on March 22, 2011, 306 days after the submission was received.
What is the product code of K101422?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.