IAB ANCHOR
FDA 510(k) clearance K922103 · decided 1993-08-03
Clearance details
- K-number
- K922103
- Device name
- IAB ANCHOR
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-06
- Decision date
- 1993-08-03
- Days to decision
- 454 days
- Clearance type
- Traditional
- Product code
- KMK
- Device class
- 1
- Regulation number
- 880.5210
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Datascope Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994) | Interrad Medical, Inc. | 2019-07-09 |
| A P HARNESS (K981860) | Paraworks Enterprise, Ltd. | 1999-06-03 |
| MULTI-PURPOSE MEDICAL TUBE HOLDER (K963365) | Byrd Medical Devices, Inc. | 1996-10-11 |
| SECURE-SITE (K941098) | Op-Co Medical Products , Ltd. | 1995-08-09 |
| STATLOCK CV (K943147) | Venetec, Inc. | 1994-09-29 |
| IV START KITS (K943047) | Sterile Concepts, Inc. | 1994-09-14 |
| IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940) | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (K941850) | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| CONMED VENI-GARD I.V. DRESSING (K935389) | Conmedcorp | 1994-03-07 |
| K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (K935252) | K-Lok, Inc. | 1994-02-18 |
| CENTERMARK SECURING WINGS (K940127) | Menlo Care, Inc. | 1994-02-09 |
| SECURODRIP (TM) I.V. ARMBOARD (K932757) | Op-Co Medical Products , Ltd. | 1993-12-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014) | Datascope Corp. | 1994-12-22 |
| HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010) | Datascope Corp. | 1992-11-16 |
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013) | Datascope Corp. | 1992-08-26 |
| HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011) | Datascope Corp. | 1991-10-04 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009) | Datascope Corp. | 1990-09-28 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005) | Datascope Corp. | 1989-05-17 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008) | Datascope Corp. | 1989-03-09 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006) | Datascope Corp. | 1988-09-09 |