BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
FDA 510(k) clearance K880637 · decided 1988-04-11
Clearance details
- K-number
- K880637
- Device name
- BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1988-02-16
- Decision date
- 1988-04-11
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- BZO
- Device class
- 1
- Regulation number
- 868.5975
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Valencia, CA, 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 |
|---|---|---|
| UNICOR, INC. CORRUGATED TUBING (K953784) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. VENTILATOR HOSES (K953785) | Unicor, Inc. | 1995-09-18 |
| PRIMA VENTILATOR HOSES (K952010) | Prima, Inc. | 1995-05-22 |
| PRIMA VOLUMN VENTILATORSS (K952022) | Prima, Inc. | 1995-05-22 |
| PRIMA CUSTOM ANESTESIA CIRCUIT (K952012) | Prima, Inc. | 1995-05-22 |
| PRIMA BREATHING BAGS (K952011) | Prima, Inc. | 1995-05-22 |
| INFANT FLOW SYSTEM (K945740) | Hamilton Medical, Inc. | 1995-03-23 |
| PRIMA, INC. CORRUGATED TUBING (K944531) | Prima, Inc. | 1994-12-02 |
| VENTILATOR HOSE (K942569) | Med-Plastics Intl., Inc. | 1994-06-10 |
| VOLUME VENTILATOR (K942572) | Med-Plastics Intl., Inc. | 1994-06-10 |
| TUBE, INHALER OXYGEN (K935582) | Puritas Health Care, Inc. | 1994-01-14 |
| STAR BREATHING CIRCUITS (K934753) | Infrasonics Corp. | 1993-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |