The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology— 510(k) K181563
Substantially EquivalentAccess Scientific, LLC
FDA 510(k) clearance K181563 for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology, Substantially Equivalent on 2018-09-26. Applicant: Access Scientific, LLC. Device class: 2.
Clearance details
- Applicant
- Access Scientific, LLC
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DQY
view allMore clearances from Access Scientific, LLC
view all- K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
- K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath
- K162322 — the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
- K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
- K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.