MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD— 510(k) K864287
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K864287 for MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD, Substantially Equivalent on 1986-11-20. Applicant: Intermedics, Inc.. Device class: 3.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code DTB
- Device class
- Class 3
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freeport, TX, US
Recent devices under product code DTB
view allMore clearances from Intermedics, Inc.
view all- K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD
- K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
- K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
- K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
- K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Adverse events under product code DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
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.