FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Abiomed 23 Fr Sheath
K Number: K201116
·
Decision Jun 15, 2020
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
19
Review Days
49
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Basic Information
- Device Name
- Abiomed 23 Fr Sheath
- K Number
- K201116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abiomed, Inc.
- Date Received
- April 27, 2020
- Decision Date
- June 15, 2020
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Abiomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252766 | 14Fr Low Profile Introducer Kit | Oct 8, 2025 | Substantially Equivalent |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Aug 6, 2024 | Substantially Equivalent |
| K221294 | preCARDIA Occlusion System | Jun 30, 2023 | Unknown |
| K223161 | OXY-1 System | Feb 23, 2023 | Substantially Equivalent |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | Oct 13, 2022 | Substantially Equivalent |
| K202330 | Impella XR Sheath Set | Dec 7, 2020 | Substantially Equivalent |
| K200109 | OXY-1 System | Oct 23, 2020 | Substantially Equivalent |
| K192769 | Impella CP Introducer | Nov 18, 2019 | Substantially Equivalent |
| K112892 | IMPELLA 2.5 PLUS CATHETER | Sep 6, 2012 | Unknown |
| K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL | Apr 27, 2011 | Substantially Equivalent |