The following data is part of a premarket notification filed by Trireme Medical, Llc with the FDA for Chocolate Xd Ptca Balloon Catheter.
| Device ID | K153682 |
| 510k Number | K153682 |
| Device Name: | Chocolate XD PTCA Balloon Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | TriReme Medical, LLC 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TriReme Medical, LLC 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-22 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M874CX141403520RX1 | K153682 | 000 |
| M874CD141403515RX1 | K153682 | 000 |
| M874CD141403510RX1 | K153682 | 000 |
| M874CD141403020RX1 | K153682 | 000 |
| M874CD141403015RX1 | K153682 | 000 |
| M874CD141403010RX1 | K153682 | 000 |
| M874CD141402520RX1 | K153682 | 000 |
| M874CD141402515RX1 | K153682 | 000 |
| M874CD141402510RX1 | K153682 | 000 |
| M874CD141402020RX1 | K153682 | 000 |
| M874CD141402015RX1 | K153682 | 000 |
| M874CD141403520RX1 | K153682 | 000 |
| M874CX141402010RX1 | K153682 | 000 |
| M874CX141403515RX1 | K153682 | 000 |
| M874CX141403510RX1 | K153682 | 000 |
| M874CX141403020RX1 | K153682 | 000 |
| M874CX141403015RX1 | K153682 | 000 |
| M874CX141403010RX1 | K153682 | 000 |
| M874CX141402520RX1 | K153682 | 000 |
| M874CX141402515RX1 | K153682 | 000 |
| M874CX141402510RX1 | K153682 | 000 |
| M874CX141402020RX1 | K153682 | 000 |
| M874CX141402015RX1 | K153682 | 000 |
| M874CD141402010RX1 | K153682 | 000 |