FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLAR BUTTON STYLE VENTURI
K Number: K904594
·
Decision Jan 28, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
16
Review Days
110
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Basic Information
- Device Name
- COLLAR BUTTON STYLE VENTURI
- K Number
- K904594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- River Medical, Inc.
- Date Received
- October 10, 1990
- Decision Date
- January 28, 1991
- Product Code
- ETD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biowy Tym Tube (TT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by River Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | Jun 11, 2003 | Substantially Equivalent |
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K944352 | SMARTDOSE III INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K945298 | SMARTFLOW I ADMINISTRATION SET | Jun 14, 1995 | Substantially Equivalent |
| K943692 | SMART DOSE(TM) | Apr 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K932895 | RIVER PUMP | Mar 31, 1994 | Substantially Equivalent |
| K933335 | RIVER VIAL ADAPTER | Mar 1, 1994 | Substantially Equivalent |
| K915120 | TEF/PLATINUM PISTON | Dec 27, 1991 | Substantially Equivalent |
| K915121 | TEF/WIRE PISTON | Dec 23, 1991 | Substantially Equivalent |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | Dec 18, 1991 | Substantially Equivalent |