FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NRG TRANSSEPTAL NEEDLE
K Number: K073326
·
Decision May 28, 2008
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
19
Applicant Total
28
Review Days
183
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Basic Information
- Device Name
- NRG TRANSSEPTAL NEEDLE
- K Number
- K073326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5175
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baylis Medical Co., Inc.
- Date Received
- November 27, 2007
- Decision Date
- May 28, 2008
- Product Code
- DXF
- 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 |
|---|---|---|---|
| DXF | Catheter, Septostomy | FDA class 2 | Cardiovascular |
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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 |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Apr 1, 2011 | 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 |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | Dec 19, 2007 | Substantially Equivalent |