STIFFER COAXIAL MICRO-INTRODUCER KIT
FDA 510(k) clearance K071574 · decided 2007-07-05
Clearance details
- K-number
- K071574
- Device name
- STIFFER COAXIAL MICRO-INTRODUCER KIT
- Applicant
- Enpath Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-08
- Decision date
- 2007-07-05
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Enpath Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micr recall (Z-0623-2017) | Greatbatch Medical | 2016-11-18 |
| MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used recall (Z-0051-2017) | Argon Medical Devices, Inc | 2016-10-07 |