VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM— 510(k) K041473
Substantially EquivalentVortran Medical Technology 1, Inc.
FDA 510(k) clearance K041473 for VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM, Substantially Equivalent on 2004-07-15. Applicant: Vortran Medical Technology 1, Inc.. Device class: 2.
Clearance details
- Applicant
- Vortran Medical Technology 1, Inc.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code BTL
view allMore clearances from Vortran Medical Technology 1, Inc.
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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 K041473
K-number listed on FDA's recall record- Z-2091-2017 — VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
- Z-2092-2017 — VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041473.
Data sourced from openFDA. This site is unofficial and independent of the FDA.