FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K Number: K132592
·
Decision Oct 9, 2014
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
190
Review Days
416
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Basic Information
- Device Name
- FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K Number
- K132592
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- August 19, 2013
- Decision Date
- October 9, 2014
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K131772 | CANTATA(R) 2.9 MICROCATHETER | Feb 20, 2014 | Substantially Equivalent |
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| 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 |