TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
FDA 510(k) clearance K955461 · decided 1997-03-19
Clearance details
- K-number
- K955461
- Device name
- TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
- Applicant
- VBM Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1997-03-19
- Days to decision
- 476 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Roy, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch VBM Medizintechnik GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizinte recall (Z-2675-2011) | VBM Medical Inc. | 2011-06-28 |
| Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizinte recall (Z-2676-2011) | VBM Medical Inc. | 2011-06-28 |
| Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet recall (Z-2010-2009) | Instrumentation Industries Inc | 2009-09-03 |