LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
FDA 510(k) clearance K051395 · decided 2005-06-24
Clearance details
- K-number
- K051395
- Device name
- LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
- Applicant
- Vascular Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-27
- Decision date
- 2005-06-24
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vascular Solutions
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| Langston Dual Lumen Catheter recall (Z-0110-2021) | Vascular Solutions, Inc. | 2020-10-20 |
| Langston Dual Lumen Catheter. recall (Z-0111-2021) | Vascular Solutions, Inc. | 2020-10-20 |
| Langston Dual Lumen Catheter. recall (Z-0112-2021) | Vascular Solutions, Inc. | 2020-10-20 |
| Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographi recall (Z-1747-2020) | Vascular Solutions, Inc. | 2020-04-27 |
| Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dua recall (Z-1981-2014) | Vascular Solutions, Inc. | 2014-07-03 |
| Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, recall (Z-2608-2010) | Vascular Solutions, Inc. | 2010-09-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031) | Vascular Solutions, Inc. | 2010-09-15 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030) | Vascular Solutions, Inc. | 2010-05-07 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028) | Vascular Solutions, Inc. | 2008-12-17 |