K171333 is an FDA 510(k) clearance for the 20G x 5/8 Pro-Lock CT Safety Infusion Set. This device is classified as a Non-coring (huber) Needle (Class II - Special Controls, product code PTI).
Submitted by Medcomp (Dba Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on July 18, 2017, 71 days after receiving the submission on May 8, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums..
| 510(k) Number | K171333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2017 |
| Decision Date | July 18, 2017 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PTI — Non-coring (huber) Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums. |