International safety notice
Technical name: Catheter Introduction Kit
Brazil / Anvisa · BRA · Oct 11, 2017
Key facts
| Title | Technical name: Catheter Introduction Kit |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Flexcath Advance - Deflectable sheath with dilator Technical name: Catheter Introduction Kit ANVISA registration number: 10339190492 Risk class: IV Affected model: 4FC12 Affected serial numbers: See attachment on the Anvisa portal. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR MUNICÍPIO SÃO PAULO SP E TELEFONE 11 21829200 FABRICANTE FABRICANTE RESPONSÁVEL MEDTRONIC CRYOCATH LP 9000 AUTOROUTE TRANSCANADIENNE POINTECLAIRE QUEBEC H9H 5H3 CANADÁ |
| Models | 10339190492, 3Fp_p_auth, 26p_p_lifecycle, 26p_p_col_count, 4FC12, 26p_p_col_pos, 3DW0KWJRtA, 2Finformacoes-tecnicas13, 26p_p_mode, alerta-2393-tecnovigilancia-medtronic-flexcath-advance-bainha-deflectivel-com-dilatador-atualizacao-do-manual-de-instrucao, 2Fportal.anvisa.gov.br, 3Dcolumn-3 and 9 more |
| Date | Oct 11, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1