510(k) K181782
- Device
- Medline Reinforced Epidural Catheter
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K181782
- Product code
- BSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-04
- Date received
- 2018-07-03
- Regulation
- 868.5120
- Classification name
- Catheter, Conduction, Anesthetic
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Claire Pigman
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers
- 2134812
- 3021006165
- 9611612
- 3004893332
- 2521402
- 9680425
- 1423507
- 3007441619
- 3011270181
- 1061124
- 3004784537
- 3015460875
- 3003767927
- 2030624
- 3014656749
- 1000563940
- 3010041511
- 2523676
- 1043214
- 3009039068
- 3009599228
- 1644312
- 3013764800
- 1316297
- 1018470
- 9680794
- 3016678045
- 3002806603
- 3016761372
- 3009888344
- 3009746061
- 3006946348
- 3015972753
- 3010170586
- 3006188722
- 2020735
- 3010321647
- 1643059
- 3011137372
- 3004365956
- 1643817
- 1417592
- 9617604
- 3003898360
- 2618282
- 9610825
- 3015859709
- 3006425876
- 3012307300
- 2029275
- 1319639
- 3015443199
- 3013162291
- 2243072
- 3003915875
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON