CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS— 510(k) K120158
Substantially EquivalentThomas Medical Products, Inc.
FDA 510(k) clearance K120158 for CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS, Substantially Equivalent on 2012-08-14. Applicant: Thomas Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Thomas Medical Products, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code DYB
view allMore clearances from Thomas Medical Products, Inc.
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 K120158
K-number listed on FDA's recall record- Z-2571-2024 — Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.
- Z-2577-2024 — Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120158.
Data sourced from openFDA. This site is unofficial and independent of the FDA.