POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER— 510(k) K121442
Substantially EquivalentCordis Corporation
FDA 510(k) clearance K121442 for POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER, Substantially Equivalent on 2012-06-14. Applicant: Cordis Corporation. Device class: 2.
Clearance details
- Applicant
- Cordis Corporation
- 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
- Special
- Location
- Bridgewater, NJ, US
Recent devices under product code LIT
view allMore clearances from Cordis Corporation
view all- K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
- K212977 — SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
- K210626 — SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
- K202167 — Brite Tip Radianz Guiding Sheath
- K201377 — SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
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 →
Recalls naming K121442
K-number listed on FDA's recall record- Z-0390-2019 — Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- Z-0998-2015 — Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.