THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006— 510(k) K081697
Substantially EquivalentAccess Scientific, Inc.
FDA 510(k) clearance K081697 for THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006, Substantially Equivalent on 2008-12-04. 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
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- 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.