PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE— 510(k) K133043
Substantially EquivalentAngioslide, Ltd.
FDA 510(k) clearance K133043 for PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE, Substantially Equivalent on 2013-12-06. Applicant: Angioslide, Ltd.. Device class: 2.
Clearance details
- Applicant
- Angioslide, Ltd.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
Recent devices under product code LIT
view allMore clearances from Angioslide, Ltd.
view all- K172494 — PROTEUS PTA Balloon Catheter with Embolic Capture Feature
- K120164 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K120805 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K111750 — EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K090364 — EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.