Intra Luminal Therapeutics, Inc.
Carlsbad, CA, US
Intra Luminal Therapeutics, Inc. appears in FDA device records in Carlsbad, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Intra Luminal Therapeutics, Inc. between 2000 and 2005. The busiest year on record is 2003, with 6. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 6 |
| 2004 | 5 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050916 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] | PDU | Substantially Equivalent | |
| K050915 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] | DQX | Substantially Equivalent | |
| K041973 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | Substantially Equivalent | |
| K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 | DQY | Substantially Equivalent | |
| K040037 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | Substantially Equivalent | |
| K033929 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | Substantially Equivalent | |
| K032031 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | Substantially Equivalent | |
| K033708 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | Substantially Equivalent | |
| K031842 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | PDU | Substantially Equivalent | |
| K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | DQY | Substantially Equivalent | |
| K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | DQY | Substantially Equivalent | |
| K031417 | ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 | DQY | Substantially Equivalent | |
| K030984 | SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT | DQY | Substantially Equivalent | |
| K021638 | ILT ADVANCING MECHANISM, MODEL A115AMI | DQX | Substantially Equivalent | |
| K021243 | ILT TORQUER, MODEL 114TR1 | DQX | Substantially Equivalent | |
| K021323 | MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | |
| K011986 | SAFE-STEER GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | |
| K012169 | ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 | DQY | Substantially Equivalent | |
| K010531 | ILT DEFLECTING CATHETER, MODEL C114ND1 | DQY | Substantially Equivalent | |
| K001992 | ILT 0.014 CATHETER, MODEL C114NL2 | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain