FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Route 92 Medical Access System
K Number: K180201
·
Decision May 23, 2018
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
13
Review Days
119
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Basic Information
- Device Name
- Route 92 Medical Access System
- K Number
- K180201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Route 92 Medical, Inc.
- Date Received
- January 24, 2018
- Decision Date
- May 23, 2018
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Route 92 Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | May 19, 2025 | Substantially Equivalent |
| K240529 | 8F Modified Sheath System | Oct 2, 2024 | Substantially Equivalent |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Apr 23, 2024 | Substantially Equivalent |
| K231583 | Route 92 Medical Full Length 054 Access System | Aug 15, 2023 | Substantially Equivalent |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | Apr 11, 2023 | Substantially Equivalent |
| K222743 | Route 92 Medical Full Length 070 Access System | Oct 4, 2022 | Substantially Equivalent |
| K210635 | Route 92 Medical Full Length 088 Access System | Jul 27, 2021 | Substantially Equivalent |
| K203043 | Route 92 Medical 070 Access System | Nov 11, 2020 | Substantially Equivalent |
| K200121 | Route 92 Medical 088 Access System, 110 cm | Apr 18, 2020 | Substantially Equivalent |
| K191717 | Route 92 Medical Sheath System | Jan 13, 2020 | Substantially Equivalent |