THE PICC WAND PEELABLE SAFETY INTRODUCER— 510(k) K093022
Substantially EquivalentAccess Scientific, Inc.
FDA 510(k) clearance K093022 for THE PICC WAND PEELABLE SAFETY INTRODUCER, Substantially Equivalent on 2010-01-20. Applicant: Access Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Access Scientific, Inc.
- 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, Inc.
view all- K121748 — THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
- K111417 — THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K111138 — THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
- K101422 — THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K101150 — PICC WAND PEELABLE SAFETY INTRODUCER
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.