Abiomed 14Fr Low Profile Introducer Kit— 510(k) K241708
Substantially EquivalentAbiomed, Inc.
FDA 510(k) clearance K241708 for Abiomed 14Fr Low Profile Introducer Kit, Substantially Equivalent on 2024-08-06. Applicant: Abiomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Abiomed, 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
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code DYB
view allMore clearances from Abiomed, Inc.
view allAdverse 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 →
Recalls naming K241708
K-number listed on FDA's recall record- Z-2599-2026 — Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
- Z-2600-2026 — Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- Z-2601-2026 — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
- Z-2602-2026 — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241708.
Data sourced from openFDA. This site is unofficial and independent of the FDA.