PulmoVia Working Channel— 510(k) K150280
Substantially EquivalentSanovas, Inc.
FDA 510(k) clearance K150280 for PulmoVia Working Channel, Substantially Equivalent on 2015-06-11. Applicant: Sanovas, Inc.. Device class: 2.
Clearance details
- Applicant
- Sanovas, Inc.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Rafael, CA, US
Recent devices under product code EOQ
view all- K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more
- K260382 — MONARCH Platform (MON-000008)
- K254037 — LungFlow Airway Catheter
- K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.