LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
FDA 510(k) clearance K072929 · decided 2007-12-07
Clearance details
- K-number
- K072929
- Device name
- LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-10-16
- Decision date
- 2007-12-07
- Days to decision
- 52 days
- Clearance type
- Special
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Integra LifeSciences Corporation
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 |
|---|---|---|
| LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020S recall (Z-1312-2019) | Integra LifeSciences Corp. | 2019-05-20 |