510(k) K954035
- Device
- ACTI-FLEX ARTERIAL EXTENSION SET
- Applicant
- R-GROUP INTL.
- 510(k) number
- K954035
- Product code
- CBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-25
- Date received
- 1995-08-28
- Regulation
- 868.1100
- Classification name
- Arterial Blood Sampling Kit
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERRY ANNE KAHN
- Address
- 2321 NW 66th Ct., Suite W-4 Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3015173212
- 1423537
- 9616567
- 1713468
- 3007329020
- 2245270
- 3009888344
- 3004519921
- 1220477
- 2648727
- 1718873
- 9616675
- 3011237704
- 1223004
- 1422634
- 3004513970
- 2028807
- 1423395
- 3005587132
- 3006191977
- 3015060216
- 3016707060
- 3004111573
- 9617604
- 3012542015
- 1523456
- 1643817
- 3002907620
- 3011087996
- 9616088
- 3012307300
- 9610126
- 1319639
- 3020460367
- 3005012805
- 1061124
- 1928237
- 3004102403
- 3005595283
- 1526863
Source Documents#
Other 510(k) Records For Product Code CBT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071269 | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | 2007-08-01 |
| K070340 | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | 2007-03-15 |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Utah Medical Products, Inc. | 1997-03-17 |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | 1995-11-20 |
| K950098 | NEEDLE SAFETY COVER | Hammer-Plane, Inc. | 1995-08-11 |
| K945719 | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM | Sherwood Medical Co. | 1995-03-16 |
| K944941 | PISTON SYRINGE | Martell Medical Products, Inc. | 1994-12-05 |
| K945485 | ABG NEEDLE PROTECTION | Devon Industries, Inc. | 1994-11-29 |
| K940575 | ASPIR-PULSE(TM) SAF-T-VENT | Sherwood Medical Co. | 1994-03-22 |
| K931873 | VACVENT | Steven Frank Mercereau | 1993-12-30 |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | Customed, Inc. | 1993-07-14 |
| K925453 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I | Sherwood Medical Co. | 1993-07-12 |
| K930471 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II | Sherwood Medical Co. | 1993-06-22 |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Concord/Portex | 1993-06-22 |
| K914778 | NEOLINE(TM) | Martech Medical Products, Inc. | 1992-09-16 |
Legacy Summary#
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FDA Review#
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