FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Instylla Microcatheter
K Number: K191731
·
Decision Aug 13, 2019
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
7
Review Days
46
Basic Information
- Device Name
- Instylla Microcatheter
- K Number
- K191731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instylla, Inc.
- Date Received
- June 28, 2019
- Decision Date
- August 13, 2019
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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Other Clearances by Instylla, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240873 | TEMBO Embolic System | Dec 16, 2024 | Substantially Equivalent |
| K213632 | Instylla Delivery Kit | Feb 10, 2022 | Substantially Equivalent |
| K210808 | Instylla Microcatheter 1.2 | Apr 15, 2021 | Substantially Equivalent |
| K202544 | Instylla Delivery Kit | Jan 7, 2021 | Substantially Equivalent |
| K200744 | Instylla Microcatheter | Apr 21, 2020 | Substantially Equivalent |
| K191659 | Instylla Delivery Kit | Oct 10, 2019 | Substantially Equivalent |