TRANSSEPTAL NEEDLE/TROCAR— 510(k) K011727
Substantially EquivalentThomas Medical Products, Inc.
FDA 510(k) clearance K011727 for TRANSSEPTAL NEEDLE/TROCAR, Substantially Equivalent on 2002-05-02. Applicant: Thomas Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Thomas Medical Products, Inc.
- Product code
- Code DRC
- Device class
- Class 2
- Regulation
- 21 CFR 870.1390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code DRC
view allMore clearances from Thomas Medical Products, Inc.
view allAdverse events under product code DRC
product code DRC- Death
- 28
- Injury
- 412
- Total
- 440
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 K011727
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 K011727.
Data sourced from openFDA. This site is unofficial and independent of the FDA.