THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL— 510(k) K121748
Substantially EquivalentAccess Scientific, Inc.
FDA 510(k) clearance K121748 for THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL, Substantially Equivalent on 2012-07-27. 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
- Special
- Location
- San Diego, CA, US
Recent devices under product code DYB
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view all- 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
- K093022 — THE 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 →
Recalls naming K121748
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 K121748.
Data sourced from openFDA. This site is unofficial and independent of the FDA.