FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARIAT sulture Delivery Device
K Number: K142241
·
Decision Sep 12, 2014
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- LARIAT sulture Delivery Device
- K Number
- K142241
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sentreheart, Inc.
- Date Received
- August 13, 2014
- Decision Date
- September 12, 2014
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sentreheart, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153096 | LARIAT RS Suture Delivery Device | Nov 25, 2015 | Substantially Equivalent |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | May 6, 2009 | Substantially Equivalent |
| K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | Aug 11, 2008 | Substantially Equivalent |
| K070126 | OCCLUSION BALLOON CATHETER | Feb 8, 2008 | Substantially Equivalent |