ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1— 510(k) K061593
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K061593 for ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1, Substantially Equivalent on 2006-07-12. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Applicant
- AtriCure, Inc.
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, OH, US
Recent devices under product code OCL
view all- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K221358 — Isolator® Linear Pen (MLP1) +4 more
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
More clearances from AtriCure, Inc.
view allAdverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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 K061593
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 K061593.
Data sourced from openFDA. This site is unofficial and independent of the FDA.