The Powerwand Safety Introducer with and Extended Dwell
FDA 510(k) K121748 · Access Scientific, Inc.
510(k) numberK121748
Submission
- Device name
- The Powerwand Safety Introducer with and Extended Dwell
- Applicant
- Access Scientific, Inc.
San Diego, CA, US - Received
- June 14, 2012
- Decision date
- July 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 and Extended Dwell cleared by the FDA?
The Powerwand Safety Introducer with and Extended Dwell (K121748) received a 510(k) decision of Substantially Equivalent on July 27, 2012, 43 days after the submission was received.
What is the product code of K121748?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.