HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
FDA 510(k) clearance K895868 · decided 1989-10-31
Clearance details
- K-number
- K895868
- Device name
- HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-10-04
- Decision date
- 1989-10-31
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- GYK
- Device class
- 1
- Regulation number
- 882.4545
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Niles, IL, 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 |
|---|---|---|
| REIGEL TUNNELING DEVICE (K962761) | Cook, Inc. | 1996-10-11 |
| V/P AND L/P CATHETER PASSERS (K934391) | Radionics, Inc. | 1993-11-19 |
| PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (K930606) | Pudenz-Schulte Medical Research Corp. | 1993-09-10 |
| CORDIS TUNNELER (K932273) | Cordis Corp. | 1993-08-23 |
| PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (K883607) | Codman & Shurtleff, Inc. | 1988-09-30 |
| HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (K873771) | American V. Mueller | 1987-12-18 |
| H-H SUBGALEAL TROCAR (K865075) | Holter-Hausner Intl. | 1987-01-13 |
| H-H CATHETER PASSERS(TACL DESIGN (K853370) | Holter-Hausner Intl. | 1985-09-18 |
| H-H SHUNT INTRODUCER (K853368) | Holter-Hausner Intl. | 1985-09-06 |
| H-H SHUNT PASSERS (K841553) | Holter-Hausner Intl. | 1984-05-14 |
| H-H SHUNT INTRODUCER (K792639) | Holter-Hausner Intl. | 1979-12-31 |
| PERITONEAL INTRODUCER & SHEATH (K771529) | Cordis Corp. | 1977-08-16 |
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 |