510(k) K150800
- Device
- Valved Safety Centesis Catheter
- Applicant
- B. Braun Medical Inc
- 510(k) number
- K150800
- Product code
- GCB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-12
- Date received
- 2015-03-26
- Regulation
- 878.4200
- Classification name
- Needle, Catheter
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nancy Skocypec
- Address
- 901 Marcon Blvd. Allentown PA US 18109 18109
FDA Registration Numbers#
- 3008717264
- 1018233
- 1060680
- 1625425
- 1061124
- 3013666218
- 3008258694
- 8040278
- 3017425975
- 3010041511
- 2433012
- 3016950436
- 3015173212
- 3012536737
- 3004111573
- 1000121056
- 2030624
- 1724474
- 3033589330
- 3013764800
- 1417485
- 1054241
- 2124215
- 2183744
- 3005273623
- 3006617533
- 3023460764
- 3015451162
- 9616662
- 1928237
- 1836161
- 3011657181
- 3015309643
- 1319639
- 1649395
- 1420054
- 9680837
- 1018470
- 1043214
- 8044098
- 3010273872
- 1820334
- 3015058854
- 3003418325
- 3033536312
- 3011642792
- 1055236
- 1828424
- 3011137372
- 2523676
- 3002807314
- 1644312
- 3004859241
- 1828132
- 3008797804
- 3012302888
- 2246552
- 3006082230
- 3004134316
- 3026310731
- 3006897996
- 1721504
- 3006950086
- 1721686
- 1721676
- 3011555199
- 3005809810
- 2521402
- 1211566
- 9681260
- 1220477
- 3004608878
- 2134812
- 3013909820
- 8030607
- 3015225571
- 3013460719
- 3044036787
- 2518902
Source Documents#
Other 510(k) Records For Product Code GCB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974146 | PARACENTESIS CATHETER DEVICE | Allegiance Healthcare Corp. | 1998-01-28 |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1993-07-22 |
| K923028 | TURKEL PNEUMOTHORAX KIT | Symbiosis Corp. | 1992-08-04 |
| K900374 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1990-04-20 |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Concord Laboratories, Inc. | 1985-11-13 |
| K852428 | MANAN EPIDURAL NEEDLE | Manan Manufacturing Co., Inc. | 1985-06-27 |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Jelco Laboratories | 1978-08-23 |
Legacy Summary#
summary
FDA Review#
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