WECK CARDIAC PACING WIRES— 510(k) K011660
Substantially EquivalentWeck Closure Systems
FDA 510(k) clearance K011660 for WECK CARDIAC PACING WIRES, Substantially Equivalent on 2001-08-21. Applicant: Weck Closure Systems. Device class: 2.
Clearance details
- Applicant
- Weck Closure Systems
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Research Triangle Park, NC, US
Recent devices under product code LDF
view all- K252042 — Sync AV II Temporary Pacing Catheter
- K242863 — Bioptimal Bipolar Pacing Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
- K241199 — Rotatable Connector (5944RL)
More clearances from Weck Closure Systems
view all- K003337 — HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
- K993157 — HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
- K982941 — HEM-O-LOK MODEL NUMBERS 523900, 523970
- K982944 — HEM-O-LOCK, MODEL 523935
- K982313 — HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
Adverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
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.