THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
FDA 510(k) clearance K091340 · decided 2009-06-09
Clearance details
- K-number
- K091340
- Device name
- THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
- Applicant
- Boston Scientific Corp
- Decision
- Unknown
- Date received
- 2009-05-06
- Decision date
- 2009-06-09
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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| NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163) | Vygon Corp. | 2011-10-13 |
| VR MEDICAL ENTERAL ORAL SYRINGE (K110853) | Vr Medical | 2011-05-13 |
| MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700) | Benlan, Inc. | 2010-12-13 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
| ORAL/ENTERAL SYRINGES (K100099) | Philips Children'S Medical Ventures | 2010-06-14 |
| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (K083776) | Corpak Medsystems | 2009-03-05 |
Recalls involving this device
No recalls on record reference this clearance.