CORDIS BIPOLAR PACER CONNECTOR SYSTEM— 510(k) K791784
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K791784 for CORDIS BIPOLAR PACER CONNECTOR SYSTEM, Substantially Equivalent on 1979-09-28. Applicant: Cordis Corp.. Device class: 3.
Clearance details
- Applicant
- Cordis Corp.
- Product code
- Code DXY
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code DXY
view all- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
More clearances from Cordis Corp.
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 DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.