Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

K-Number: K872917 · 1987-08-11

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1987-08-11
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1987-08-11 under 510(k) number K872917. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER?

JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER is a medical device that received FDA 510(k) clearance on 1987-08-11. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K872917.

When did JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER receive FDA 510(k) clearance?

JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER received FDA 510(k) clearance on 1987-08-11, under 510(k) number K872917.

Who is the listed applicant for JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER?

The FDA product code for JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER is BSY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Pharmaseal Div. Ahsc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK871429ANTIMICROBIAL FOLEY CATHETER

View all 64 devices →

Related Devices (Code: BSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑