FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K Number: K071049
·
Decision Oct 16, 2007
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
14
Review Days
186
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Basic Information
- Device Name
- DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
- K Number
- K071049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tyco Healthcare
- Date Received
- April 13, 2007
- Decision Date
- October 16, 2007
- Product Code
- EZL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Tyco Healthcare
| K Number | Device Name | ||
|---|---|---|---|
| K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | Sep 14, 2007 | Substantially Equivalent |
| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | Sep 12, 2007 | Substantially Equivalent |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | Aug 3, 2006 | Substantially Equivalent |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | Jan 18, 2005 | Substantially Equivalent |
| K040897 | DOVER ROB-NEL CATHETER | Jul 20, 2004 | Substantially Equivalent |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | Jul 15, 2004 | Substantially Equivalent |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Jul 7, 2004 | Substantially Equivalent |
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE | Jun 30, 2004 | Substantially Equivalent |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | Apr 29, 2004 | Substantially Equivalent |
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Dec 8, 2003 | Substantially Equivalent |