MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59— 510(k) K083855
Substantially EquivalentAcumen Medical, Inc.
FDA 510(k) clearance K083855 for MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59, Substantially Equivalent on 2009-02-17. Applicant: Acumen Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Acumen Medical, 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
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code DYB
view allMore clearances from Acumen Medical, Inc.
view all- K080500 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
- K070396 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
- K070051 — ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
- K070197 — ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
- K062145 — MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.