CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA— 510(k) K032737
Substantially EquivalentCordis Europa, N.V.
FDA 510(k) clearance K032737 for CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA, Substantially Equivalent on 2003-10-02. Applicant: Cordis Europa, N.V.. Device class: 2.
Clearance details
- Applicant
- Cordis Europa, N.V.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warren, NJ, US
Recent devices under product code DQY
view allMore clearances from Cordis Europa, N.V.
view all- K071189 — CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
- K063563 — CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
- K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
- K043605 — INSCOPE 3-STAGE BALLOON DILATOR
- K040413 — CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K032737
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 K032737.
Data sourced from openFDA. This site is unofficial and independent of the FDA.