FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K Number: K140593
·
Decision Dec 15, 2014
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
190
Review Days
283
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Basic Information
- Device Name
- ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
- K Number
- K140593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- March 7, 2014
- Decision Date
- December 15, 2014
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Cook, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | Jan 9, 2015 | Substantially Equivalent |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | Oct 9, 2014 | Substantially Equivalent |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Apr 18, 2014 | Substantially Equivalent |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | Feb 20, 2014 | Substantially Equivalent |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | Jan 29, 2014 | Substantially Equivalent |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | Dec 23, 2013 | Substantially Equivalent |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Oct 25, 2013 | Substantially Equivalent |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | Oct 7, 2013 | Substantially Equivalent |
| K131206 | COOK CERVICAL RIPENING BALLOON | Sep 27, 2013 | Substantially Equivalent |
| K132334 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | Aug 16, 2013 | Substantially Equivalent |