FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Breezeway II
K Number: K210627
·
Decision Jun 3, 2021
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
49
Review Days
93
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
- Breezeway II
- K Number
- K210627
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oscor, Inc.
- Date Received
- March 2, 2021
- Decision Date
- June 3, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Oscor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151951 | Destino Reach | Sep 22, 2015 | Substantially Equivalent |
| K143463 | IS4/DF4 Port Plug | Mar 19, 2015 | Substantially Equivalent |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | Jul 9, 2014 | Substantially Equivalent |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | Apr 17, 2014 | Substantially Equivalent |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | Feb 13, 2014 | Substantially Equivalent |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | Jan 8, 2014 | Substantially Equivalent |
| K130104 | GUIDEWIRE, PURSUER SERIES | Jun 13, 2013 | Substantially Equivalent |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | Dec 13, 2012 | Substantially Equivalent |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | Dec 13, 2012 | Substantially Equivalent |
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | Aug 29, 2012 | Substantially Equivalent |