SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER— 510(k) K133843
Substantially EquivalentCordis Corporation
FDA 510(k) clearance K133843 for SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER, Substantially Equivalent on 2014-06-27. 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
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code LIT
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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 K133843
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 K133843.
Data sourced from openFDA. This site is unofficial and independent of the FDA.