SECURE ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k) clearance K070340 · decided 2007-03-15
Clearance details
- K-number
- K070340
- Device name
- SECURE ARTERIAL BLOOD SAMPLING SYSTEM
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-06
- Decision date
- 2007-03-15
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- CBT
- Device class
- 1
- Regulation number
- 868.1100
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (K071269) | Smiths Medical Asd, Inc. | 2007-08-01 |
| ABC IN-LINE BLOOD SAMPLING KIT (K955663) | Utah Medical Products, Inc. | 1997-03-17 |
| ABG POINT LOK NEEDLE PROTECTION DEVICE (K954015) | Devon Industries, Inc. | 1995-11-20 |
| ACTI-FLEX ARTERIAL EXTENSION SET (K954035) | R-Group Intl. | 1995-09-25 |
| NEEDLE SAFETY COVER (K950098) | Hammer-Plane, Inc. | 1995-08-11 |
| ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (K945719) | Sherwood Medical Co. | 1995-03-16 |
| PISTON SYRINGE (K944941) | Martell Medical Products, Inc. | 1994-12-05 |
| ABG NEEDLE PROTECTION (K945485) | Devon Industries, Inc. | 1994-11-29 |
| ASPIR-PULSE(TM) SAF-T-VENT (K940575) | Sherwood Medical Co. | 1994-03-22 |
| VACVENT (K931873) | Steven Frank Mercereau | 1993-12-30 |
| BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 (K930986) | Customed, Inc. | 1993-07-14 |
| SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I (K925453) | Sherwood Medical Co. | 1993-07-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |