The following data is part of a premarket notification filed by Intuit Medical, Llc with the FDA for Dk-ptca Balloon Catheter.
| Device ID | K123264 |
| 510k Number | K123264 |
| Device Name: | DK-PTCA BALLOON CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | INTUIT MEDICAL, LLC 6018 EAGLE'S REST TRAIL Sugar Hill, GA 30518 |
| Contact | Jack C Griffis |
| Correspondent | Jack C Griffis INTUIT MEDICAL, LLC 6018 EAGLE'S REST TRAIL Sugar Hill, GA 30518 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2013-01-16 |
| Summary: | summary |