FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDD
K Number: K924997
·
Decision Mar 28, 1995
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
6
Review Days
907
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
- EDD
- K Number
- K924997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arc Medical, Inc.
- Date Received
- October 2, 1992
- Decision Date
- March 28, 1995
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTR), ordered by most recent decision date.
Spiro-VISTA
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
FDA 510(k)
FDA Class 2
·Anesthesiology
AeroJet Ventilation Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
FDA 510(k)
FDA Class 2
·Anesthesiology
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Arc Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | Jul 27, 2009 | Substantially Equivalent |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | Apr 13, 2007 | Substantially Equivalent |
| K011212 | FILTERFLO H | Dec 20, 2001 | Substantially Equivalent |
| K982239 | CIRCUIT GUARD | Aug 14, 1998 | Substantially Equivalent |
| K924627 | XTEND CIRCUITS (TM) | Apr 7, 1993 | Substantially Equivalent |