PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE— 510(k) K972201
Substantially EquivalentSulzer Carbomedics, Inc.
FDA 510(k) clearance K972201 for PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE, Substantially Equivalent on 1998-04-14. Applicant: Sulzer Carbomedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sulzer Carbomedics, Inc.
- Product code
- Code DXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3470
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code DXZ
view allMore clearances from Sulzer Carbomedics, Inc.
view allAdverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
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 K972201
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 K972201.
Data sourced from openFDA. This site is unofficial and independent of the FDA.