THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH— 510(k) K131148
Substantially EquivalentAccess Scientific, LLC
FDA 510(k) clearance K131148 for THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH, Substantially Equivalent on 2013-09-04. Applicant: Access Scientific, LLC. Device class: 2.
Clearance details
- Applicant
- Access Scientific, LLC
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DYB
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
- K181563 — The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
- K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath
- K162322 — the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
- K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.