ER-REBOA PLUS Catheter— 510(k) K193440
Substantially EquivalentPrytime Medical Devices, Inc.
FDA 510(k) clearance K193440 for ER-REBOA PLUS Catheter, Substantially Equivalent on 2020-01-09. Applicant: Prytime Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Prytime Medical Devices, Inc.
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boerne, TX, US
Recent devices under product code MJN
view allMore clearances from Prytime Medical Devices, Inc.
view allAdverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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 K193440
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 K193440.
Data sourced from openFDA. This site is unofficial and independent of the FDA.