FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
ReCross
K Number: K210431
·
Decision Jul 15, 2021
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
8
Review Days
153
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ReCross
- K Number
- K210431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imds Operations B.V.
- Date Received
- February 12, 2021
- Decision Date
- July 15, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Imds Operations B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Apr 17, 2025 | Substantially Equivalent |
| K241611 | ShapeIT (SI014135) | Sep 3, 2024 | Substantially Equivalent |
| K223728 | Micro Rx | Jul 13, 2023 | Substantially Equivalent |
| K210110 | Guidion | Mar 31, 2021 | Substantially Equivalent |
| K200324 | NHancer Rx | Aug 6, 2020 | Substantially Equivalent |
| K191229 | TrapIt | Jan 21, 2020 | Substantially Equivalent |
| K121077 | NHANCER | Dec 21, 2012 | Substantially Equivalent |