FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TORFLEX TRANSSEPTAL GUIDING SHEATH
K Number: K102948
·
Decision Apr 1, 2011
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
28
Review Days
178
Basic Information
- Device Name
- TORFLEX TRANSSEPTAL GUIDING SHEATH
- K Number
- K102948
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- October 5, 2010
- Decision Date
- April 1, 2011
- 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.
AuST Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Prelude Wave Hydrophilic Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
PeriCross Epicardial Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath Optima introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
iSLEEVE Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ViaOne Epicardial Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by BAYLIS MEDICAL CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | Jan 24, 2013 | Substantially Equivalent |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | Mar 13, 2012 | Substantially Equivalent |
| K102192 | INDISCAL DIGITAL MANOMETER | Feb 23, 2011 | Substantially Equivalent |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | Aug 10, 2010 | Substantially Equivalent |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | Jul 28, 2010 | Substantially Equivalent |
| K101117 | LEV-OR DILATION CATHETER OTW | Jul 16, 2010 | Substantially Equivalent |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | Nov 17, 2009 | Substantially Equivalent |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | Oct 16, 2009 | Substantially Equivalent |
| K073326 | NRG TRANSSEPTAL NEEDLE | May 28, 2008 | Substantially Equivalent |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | Dec 19, 2007 | Substantially Equivalent |