FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K Number: K183464
·
Decision Mar 13, 2019
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
96
Applicant Total
86
Review Days
89
Basic Information
- Device Name
- AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
- K Number
- K183464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- December 14, 2018
- Decision Date
- March 13, 2019
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NRY), ordered by most recent decision date.
Raptor Aspiration Catheter; Balt Aspiration Tubing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
APRO 45 Catheter and Alembic Aspiration Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
APRO 55 Swift Catheter and Alembic Aspiration Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Stryker
| K Number | Device Name | ||
|---|---|---|---|
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Sep 20, 2023 | Substantially Equivalent |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | May 19, 2023 | Substantially Equivalent |
| K230754 | L12 LED Light Source with AIM | Apr 11, 2023 | Substantially Equivalent |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Mar 31, 2023 | Substantially Equivalent |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Feb 23, 2023 | Substantially Equivalent |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Aug 19, 2022 | Substantially Equivalent |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Aug 11, 2022 | Substantially Equivalent |
| K221611 | 780 nm L11 LED Light Source with AIM | Jun 29, 2022 | Substantially Equivalent |
| K221217 | SPY Laparoscope | Jun 17, 2022 | Substantially Equivalent |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | May 25, 2022 | Substantially Equivalent |