CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM— 510(k) K970392
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K970392 for CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM, Substantially Equivalent on 1997-04-24. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
Recent devices under product code DRE
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view all- K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
- K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- K082143 — MICRO GUIDE CATHETER XP
- K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
Adverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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 K970392
K-number listed on FDA's recall record- Z-2079-2021 — Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Z-1174-2016 — CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970392.
Data sourced from openFDA. This site is unofficial and independent of the FDA.