THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER— 510(k) K131300
Substantially EquivalentAccess Scientific, LLC
FDA 510(k) clearance K131300 for THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER, Substantially Equivalent on 2013-06-07. 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
- Special
- 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
- K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
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 →
Recalls naming K131300
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.