Panels › Cardiovascular › Product code DTL · Class 2
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation 870.4290
0510(k)s in 12 months (137 all time)
5recalls in 12 months (59 all time)
46recalls that name a 510(k)
Top companies in DTL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | K782095 |
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | K782095 |
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | K782095 |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061;
2 Open, Classified |
DTL | None listed |
| Nov 17, 2025 | Merit Medical Systems, Inc. PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP80 Open, Classified |
DTL | None listed |
| Sep 11, 2025 | Merit Medical Systems, Inc. 10Fore Hemostasis Valve
Catalog Number / UDI-DI code:
MAPTEN4 / 00884450821305
MAPTEN42 / 00884450832509
MAPTEN452 / 00884450821329
The 10Fore Hemostasis Valve is intended to maintain hemostasis duri Open, Classified |
DTL | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;
2) KIT LEFT HEART-VA MED, Pack Number 132701;
3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;
4) K Open, Classified |
DTL | None listed |
| May 16, 2023 | Boston Scientific Corporation WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package) Open, Classified |
DTL | K172453 |
| May 16, 2023 | Boston Scientific Corporation WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) Open, Classified |
DTL | K172453 |
| Mar 1, 2022 | Merit Medical Systems, Inc. AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05 Open, Classified |
DTL | None listed |
| Mar 1, 2022 | Merit Medical Systems, Inc. Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-021 Open, Classified |
DTL | None listed |
| Aug 6, 2021 | Medline Industries Inc NAMIC Stopcocks:
(1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile;
(2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, Terminated |
DTL | K782095 K842829 |
| Aug 6, 2021 | Medline Industries Inc NAMIC Manifolds.
(1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile;
(2) NAMIC Angiographic MAN Terminated |
DTL | K782095 K842829 |
| Apr 24, 2020 | LivaNova USA Inc. 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000
/ 00803622123184 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 Terminated |
DTL | K833322 |
| Nov 18, 2019 | LivaNova USA Inc. LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Terminated |
DTL | K833322 |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM
Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The conne Terminated |
DTL | None listed |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM
Product Usage:
The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The conne Terminated |
DTL | None listed |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM
Product Usage:
The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec Terminated |
DTL | None listed |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM
Product Usage:
The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec Terminated |
DTL | None listed |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS
Product Usage:
The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The co Terminated |
DTL | None listed |
| May 9, 2018 | Cook Inc. Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM
Product Usage:
The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connec Terminated |
DTL | None listed |
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Antegrade/Retrograde Adapter
Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate Terminated |
DTL | K900994 |
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Extension Line Adapters 20 in length
Used to extend cardioplegia line during cardiopulmonary bypass surgery Terminated |
DTL | K790564 |
| Jun 27, 2017 | Terumo Cardiovascular Systems Corporation Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J
Catalog numbers:
US distribution:
LH130
74369
71156 Terminated |
DTL | K820297 |
| Jun 27, 2017 | Terumo Cardiovascular Systems Corporation TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J Terminated |
DTL | K820297 |
| Apr 7, 2016 | Vascular Solutions, Inc. Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50.
Product Usage: The Guardian hemostasis valves Terminated |
DTL | K122301 |
| Jun 23, 2015 | Terumo Cardiovascular Systems Corp Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves.
For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. Terminated |
DTL | K820297 |
| Nov 6, 2014 | Dokitz NovoSci Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014 Terminated |
DTL | K801404 |
| Mar 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass.
Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, F Terminated |
DTL | K092711 K101113 +1 |
| Oct 25, 2012 | Sorin Group USA, Inc. Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/3 Terminated |
DTL | K833322 |
| Oct 25, 2012 | Sorin Group USA, Inc. Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15.
Product Usage: The conne Terminated |
DTL | K833322 |
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